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Fujifilm

Fujifilm AMULET Innovality 

Provide your patients with a comfortable, accurate, and fast mammography experience. The AMULET Innovality is a digital mammography system that produces crisp, clear, high-resolution images at a low X-ray dose.

Installation & logistics included Sold in Caribbean, Puerto Rico and US
  • Aumulet Innovality – Medical Outfitters – Mammography System – System View – New

 

Overview

Fujifilm AMULET Innovality: Digital Mammography and Tomosynthesis

Authorized Fujifilm mammography equipment supplier. The AMULET Innovality uses Fujifilm technology to produce clear images without subjecting patients to excessive radiation. Mammograms are fast, with images captured at intervals of just 15 seconds, which means a better experience for patients and the ability to serve more patients in the same time frame. Use the AMULET Innovality for routine screening, or get deeper diagnostic information through an advanced biopsy system that allows vertical and lateral needle positions for precise targeting of lesions in hard-to-reach places.

The Innovality employs a Fujifilm a-Se direct conversion flat panel detector built on a Hexagonal Close Pattern array with a 50 micron pixel size for sharper images than traditional square pixel panels. DYN II Dynamic Visualization II images thick and dense breast tissue with high contrast and no saturation, ISC with a Tungsten target keeps the dose low without sacrificing contrast, and tomosynthesis reveals the internal structure of the breast to reduce false positives and false negatives. The AMULET Harmony comfort suite keeps patients relaxed throughout.

a-Se DirectHCP 50 µm Detector
15 SecondsImage Interval
ST and HRTomosynthesis Modes
Vertical + LateralBiopsy Targeting
DYN IIDense Breast Contrast
AMULET HarmonyPatient Comfort

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Key Features

Tomosynthesis, Advanced Biopsy, and AMULET Harmony Comfort

Fujifilm redefines the mammogram experience with the AMULET Innovality. A unique detector, tomosynthesis, an advanced biopsy system, and patient comfort solutions serve screening facilities of all sizes. Full technical detail is in the expandable sections below.

Hexagonal Direct Conversion Detector: an amorphous selenium direct conversion flat panel detector on a Hexagonal Close Pattern array collects signal efficiently for a higher DQE, low noise, and a 50 micron pixel size, the finest available with a direct conversion detector
15 Second Image Interval: low-noise, high-speed switching enables tomosynthesis at a low dose with a fast 15 second interval from one shot to the next
ISC on a Tungsten Target: Image-based Spectrum Conversion adjusts contrast for mammary gland density and fat so a high energy, low-dose Tungsten beam keeps the contrast of a Molybdenum target without the dose
DYN II Dynamic Visualization II: provides consistent density across glandular and adipose tissue and high contrast with no saturation, which improves imaging of thick and dense breasts
Intelligent AEC: analyzes low-dose preshot images to set the optimal X-ray energy and dose by breast type, and works even in the presence of implants
CEDM and Breast Density: contrast-enhanced digital mammography in one compression and automatic mammary gland volume measurement for breast density classification

Advanced Biopsy System: a 50 micron biopsy solution supports both stereotactic and tomosynthesis-guided targeting, with tomosynthesis available in Standard and High Resolution modes to find lesions not visible on a 2D image
Vertical and Lateral Needle Positioning: a lateral approach adapter allows access to the compressed breast from two directions for precise targeting of lesions in difficult positions, with CNB, FNB, hook wire, and VAB needles supported
Ergonomic Biopsy Workflow: ergonomic arm rests, flexible tube and detector positioning from -90 to +90 degrees, full automatic AEC for scout and tomosynthesis exposures, and the ability to view prior images during the procedure
AMULET Harmony Comfort: warm indirect mood lighting, five decorative stand labels, and Shift and Fit Sweet compression paddles create a calm, comfortable exam environment
Comfort Comp: automatic compression reduction lowers compression pressure after positioning within a small range to reduce pain without changing breast thickness or image quality
Workstation and Display: a dedicated mammography acquisition workstation with an integrated X-ray controller, an optional high definition second monitor, and a patient information display in seven languages

How the AMULET Innovality compares against conventional 2D-only mammography:

Conventional 2D Mammography
Imaging2D projection only
Dense BreastOverlapping tissue hides lesions
DetectorSquare pixel TFT common
Biopsy2D stereotactic only
Contrast StudyStandard
ComfortBasic compression
Fujifilm AMULET Innovality
Imaging2D plus tomosynthesis
Dense BreastDYN II contrast, tomo slices
Detectora-Se direct HCP 50 micron
BiopsyStereotactic and tomo-guided
Contrast StudyCEDM in one compression
ComfortAMULET Harmony, Comfort Comp
From Screening to Tomosynthesis-Guided Biopsy

The AMULET Innovality covers the full breast care pathway on one platform. Routine screening benefits from the fast 15 second interval and low dose, tomosynthesis reveals lesions hidden by overlapping tissue in dense breasts, and contrast-enhanced mammography adds functional information in a single compression. When a finding needs further work up, the advanced biopsy system targets it stereotactically or with tomosynthesis and approaches it vertically or laterally, all while AMULET Harmony keeps the patient comfortable and still.

Specifications

Full Technical Specifications

Complete reference data for capital procurement, RFP submissions, and biomedical review. Breast imaging directors, radiologists, and biomedical engineers rely on this specification set when they evaluate a digital mammography and tomosynthesis system. Expand each category for full detail.

DetectorAmorphous selenium, a-Se, direct conversion flat panel detector
Pixel ArrayHexagonal Close Pattern, HCP, TFT array
Pixel Size50 microns, the finest available with a direct conversion detector
Image QualityHigher DQE than square pixel panels, low noise, high-speed switching
Image IntervalApproximately 15 seconds from one shot to the next

ISCImage-based Spectrum Conversion adjusts contrast on a Tungsten target for low dose
DYN IIDynamic Visualization II for high contrast without saturation in thick and dense breasts
Intelligent AECSets X-ray energy and dose by breast type from preshot analysis, works with implants
CEDMContrast-enhanced digital mammography with low and high energy subtraction in one compression
Breast DensityAutomatic mammary gland volume measurement, also from tomosynthesis images

Standard ModePlus or minus 7.5 degree acquisition angle, fast and low dose for screening
High Resolution ModePlus or minus 20 degree acquisition angle for greater depth resolution
ReconstructionIterative Super Reconstruction for dose reduction and fine structure restoration
S-ViewAutomatically produced synthesized 2D image alongside 1 millimeter tomographic slices
Dose2D dose reduced by approximately 30 percent, combined 2D and tomosynthesis at 2 mGy or less

GuidanceStereotactic and tomosynthesis-guided targeting in Standard and High Resolution modes
Needle PositioningVertical and lateral with a lateral approach adapter, two-direction access
NeedlesCNB, FNB, hook wire, and VAB needles across a wide range of sizes
AECFull automatic AEC for scout 2D and tomosynthesis exposures
PositioningTube and detector positioning from -90 to +90 degrees with ergonomic arm rests
Resolution50 micron biopsy image solution with prior image viewing

Acquisition WorkstationDedicated mammography AWS with an integrated X-ray controller and 1, 2, or 4 image display
Second MonitorOptional high definition 3M or 5M second monitor for prior and reconstructed images
Patient DisplayPatient information display in seven supported languages
AMULET HarmonyMood lighting, five decorative labels, Shift and Fit Sweet paddles, and Comfort Comp
Diagnostic WorkstationAMULET Bellus II multi-modality diagnostic workstation
Quality ControlFujifilm Mammography QC Program for stable image quality
Use Cases

Clinical Applications

Deployed across breast imaging programs where screening, tomosynthesis for dense breasts, contrast-enhanced mammography, and image-guided biopsy come together on one comfortable platform.

Workflow

From Comfortable Positioning to Image-Guided Biopsy

A breast imaging workflow built for speed, image quality, and comfort. Relaxed positioning, fast 2D and tomosynthesis acquisition, advanced image optimization, and image-guided biopsy move the patient from screening to diagnosis. Expanded workflow details are in the expandable sections below.

The patient is positioned with ergonomic arm rests under warm indirect mood lighting, with a decorative stand label chosen to suit the room. A Shift or Fit Sweet compression paddle applies even compression, and Comfort Comp automatic decompression reduces pressure after positioning to ease discomfort without changing breast thickness.

Intelligent AEC analyzes a low-dose preshot to set the optimal X-ray energy and dose by breast type, even with implants. The a-Se Hexagonal Close Pattern detector then captures 2D and tomosynthesis images, with a fast 15 second interval between shots in Standard mode and High Resolution mode available for greater depth resolution.

ISC adjusts contrast for a low-dose Tungsten beam, DYN II provides high contrast without saturation in dense breast tissue, and Iterative Super Reconstruction reduces dose while restoring the fine structure of calcifications. An S-View synthesized 2D image is produced automatically alongside the tomographic slices for comprehensive reading.

When a finding needs work up, the advanced biopsy system targets it with stereotactic or tomosynthesis guidance and a vertical or lateral needle approach, viewing prior images during the procedure. Images output immediately to PACS, a viewer, or a printer, and the AMULET Bellus II workstation supports efficient multi-modality reading.

Certifications

Regulatory Compliance and Safety

FDA cleared for digital mammography and tomosynthesis, manufactured by FUJIFILM Corporation of Japan. Medical Outfitters is an ISO 13485:2016 certified supplier of imaging equipment, so every Fujifilm AMULET Innovality ships through a documented and audited quality management system. Full compliance documentation is available in the expandable sections below.

FDA Cleared: the Fujifilm AMULET Innovality digital mammography and tomosynthesis system is FDA cleared.
ISO 13485: Medical Outfitters Inc. is independently ISO 13485:2016 certified as a supplier, so every system ships through a fully audited quality management system.
CE Marking: system components are CE marked for their respective class.

Low Dose: Iterative Super Reconstruction reduces tomosynthesis dose, combined 2D and tomosynthesis imaging is available at 2 mGy or less, and intelligent AEC tailors dose to each breast type.
Quality Control: the Fujifilm Mammography QC Program monitors system performance to maintain stable image quality for screening and diagnosis.

Manufacturer: the AMULET Innovality is manufactured by FUJIFILM Corporation of Tokyo, Japan.
Integration: images output to PACS, viewers, and printers, and the AMULET Bellus II diagnostic workstation supports multi-modality reading across MG, CT, PT, MR, CR, DX, and US.

Screening & Biopsy Configuration Review

Tell us your screening volume and whether you need the advanced biopsy option and CEDM. Our team confirms the configuration, the acquisition and diagnostic workstations, and arranges installation and applications training.

Capital Equipment & RFP Support

Pricing, technical documentation, and logistics for mammography deployments. We support breast imaging directors, radiologists, and purchasing departments evaluating digital mammography and tomosynthesis systems. Contact us for RFP packages.

FAQ

Frequently Asked Questions

Quick answers to the most common purchase and clinical questions about the Fujifilm AMULET Innovality digital mammography and tomosynthesis system. Tap any question to expand.

The Fujifilm AMULET Innovality is a digital mammography and tomosynthesis system that uses Fujifilm a-Se direct conversion flat panel detector technology to produce clear images at a low X-ray dose. It supports routine screening, digital breast tomosynthesis, contrast-enhanced mammography, and an advanced biopsy system, with a fast 15 second image interval that improves both the patient experience and department throughput.

Both share Fujifilm 50 micron Hexagonal Close Pattern direct conversion detector technology, Tungsten ISC, tomosynthesis, CEDM, and intelligent AEC. The AMULET Innovality is the established flagship known for its advanced stereotactic and tomosynthesis-guided biopsy system with vertical and lateral needle positioning and the AMULET Harmony comfort suite, while the Amulet Sophinity is the newer, space-saving model with AI positioning support. Our team helps match the right platform to your screening and biopsy needs.

The Innovality uses a direct conversion flat panel detector made of amorphous selenium, a-Se, on a Hexagonal Close Pattern array. The hexagonal pixels collect electrical signals efficiently for a higher detective quantum efficiency than conventional square pixel panels, with low noise, high-speed switching, and a 50 micron pixel size, the finest available with a direct conversion detector.

The Innovality offers two tomosynthesis modes. Standard mode uses a plus or minus 7.5 degree acquisition angle for fast, low-dose scanning suited to screening and follow-up, and High Resolution mode uses a plus or minus 20 degree angle for greater depth resolution on a region of interest. Iterative Super Reconstruction reduces dose and restores fine structure, and an S-View synthesized 2D image is produced automatically alongside 1 millimeter tomographic slices.

Yes. The advanced biopsy system supports both stereotactic and tomosynthesis-guided targeting, and a lateral approach adapter allows needle positioning both vertically and laterally so the compressed breast can be accessed from two directions for precise targeting of difficult lesions. It works with CNB, FNB, hook wire, and VAB needles, supports full automatic AEC for scout and tomosynthesis exposures, and allows prior images to be viewed during the procedure.

AMULET Harmony is a suite of comfort solutions that includes warm indirect mood lighting to ease anxiety, five selectable decorative stand labels to soften the room, Shift and Fit Sweet compression paddles for even, comfortable compression, and Comfort Comp automatic compression reduction that lowers compression pressure after positioning to reduce pain without changing breast thickness.

Yes. The Fujifilm AMULET Innovality digital mammography and tomosynthesis system is FDA cleared. Medical Outfitters Inc. is ISO 13485:2016 certified as the supplying distributor, so every system ships through an audited quality management system. It is manufactured by FUJIFILM Corporation.

Through Medical Outfitters Inc., ISO 13485:2016 certified, Miami, FL. We supply the system with its acquisition workstation, biopsy option, and accessories, and provide nationwide installation and training. Call (305) 885-4045 or request a quote online.

Complete Your Breast Program

Compatible Equipment

Breast imaging equipment commonly deployed alongside the AMULET Innovality, from the Amulet Sophinity and Aspire Cristalle mammography platforms to the Mammotome Revolve biopsy system that completes a full breast care suite.

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