Full Field Digital, System, X-ray, Mammographic

Product Code: MUE

Radiology Medical Diagnostic X-Ray Equipment

Definition: Radiation Emitting Electronic Product Codes // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Co

Applicable Standards: Diagnostic X-ray Systems And Their Major Components. [1020.30] Radiographic Equipment. [1020.31] Fluoroscopic Equipment. [1020.32] Computed Tomography (CT) Equipment. [1020.33]

Code of Federal Regulations: 892.1715


Radiation TypeIonizing
Radition SafetyProduct
Annual ReportsYes

Products Classified as MUE

5394Full Field Digital, System, X-ray, MammographicFull-field Digital Mammography System.

Total Product Life Cycle (TPLC) Devices

5394Full Field Digital, System, X-ray, MammographicFull-field Digital Mammography System.

FDA Consensus Standards

Full Field Digital, System, X-Ray, Mammographic [22382]21 CFR §892.1715 🔎
Full Field Digital, System, X-Ray, Mammographic [20192]21 CFR §892.1715 🔎
Full Field Digital, System, X-Ray, Mammographic [28636]21 CFR §892.1715 🔎
Full Field Digital, System, X-Ray, Mammographic [22380]21 CFR §892.1715 🔎

Pre-market Approvals for MUE

P990066SENOGRAPHE 2000 D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEMGE Healthcare
P010025LORAD DIGITAL BREAST IMAGERHOLOGIC, INC.

Pre-market Notifications for MUE

K212873Aspire CristalleFUJIFILM Corporation
K211725Senographe PristinaGE Healthcare
K2029022430MCA With Xmaru WRayence Co., Ltd
K202822HelianthusMetaltronica Spa
K200424Giotto Class (Models - 3000X-YY And 4000X-YY)IMS GIOTTO S.p.A.
K193334Pristina Serena BrightGE Healthcare
K193166MAMMOMAT RevelationSiemens Medical Solutions USA, Inc.
K192317Planmed Clarity 2D And Clarity SPlanmed Oy
K190809Sample Imaging For Senographe PristinaGE Healthcare
K182951Pristina Serena 3DGE Healthcare
K173576Pristina SerenaGE Healthcare
K173408Mammomat RevelationSiemens Medical Solutions, Inc.
K173132ASPIRE CristalleFujifilm Medical Systems U.S.A., Inc.
K172404SenoBright HDGE Healthcare
K172027Adani MammoScanADANI

Global Unique Device Identification Database

00884838071001Full field digital,system,x-ray,mammographic
00884838070943Full field digital,system,x-ray,mammographic
06430035430079Full Field Digital, System, X-Ray, Mammographic
06430035430024Full Field Digital,System,X-Ray,Mammographic
05414904050385Full field digital,system,x-ray,mammographic
05414904044179Full field digital,system,x-ray,mammographic
05414904044162Full field digital,system,x-ray,mammographic
05414904044155Full field digital,system,x-ray,mammographic
04547410373363Full field digital,system,x-ray,mammographic
04547410359886Full field digital,system,x-ray,mammographic
04547410354584Full field digital,system,x-ray,mammographic
04547410347517Full field digital,system,x-ray,mammographic
04547410336047Full field digital,system,x-ray,mammographic
04547410327359Full field digital,system,x-ray,mammographic
04547410327342Full field digital,system,x-ray,mammographic

Maude Adverse Events

PHILIPS MICRODOSE SI (MODEL: L50)PHILIPS MEDICAL SYSTEMS2020-03-30
SELENIA DIMENSIONSHOLOGIC, INC.2020-03-26
SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMHOLOGIC, INC2020-03-24
SELENIA MAMMOGRAPHY SYSTEMHOLOGIC, INC2020-03-20
SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMHOLOGIC, INC2020-03-17
SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMHOLOGIC, INC2020-03-16
SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMHOLOGIC, INC2020-03-16
SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMHOLOGIC, INC2020-03-03
SELENIA MAMMOGRAPHY SYSTEMHOLOGIC, INC2020-03-03
SELENIA MAMMOGRAPHY SYSTEMHOLOGIC, INC2020-03-03
SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMHOLOGIC, INC2020-02-28
SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMHOLOGIC, INC2020-02-20
SELENIA MAMMOGRAPHY SYSTEMHOLOGIC, INC2020-02-18
MAMMOMAT REVELATIONSIEMENS HEALTHCARE GMBH2020-02-14
SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMHOLOGIC, INC2020-02-14
MAMMOMAT REVELATIONSIEMENS HEALTHCARE GMBH2020-02-12
SELENIA MAMMOGRAPHY SYSTEMHOLOGIC, INC2020-02-07
SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMHOLOGIC, INC2020-02-03
SELENIA MAMMOGRAPHY SYSTEMHOLOGIC, INC2020-01-29
SELENIA MAMMOGRAPHY SYSTEMHOLOGIC, INC2020-01-27
SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMHOLOGIC, INC2020-01-24
SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMHOLOGIC, INC2020-01-24
SELENIA MAMMOGRAPHY SYSTEMHOLOGIC, INC2020-01-22
MAMMOMAT REVELATIONSIEMENS HEALTHCARE GMBH2020-01-14
DIMENSIONSHOLOGIC, INC.2020-01-13
SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMHOLOGIC, INC2020-01-09
SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMHOLOGIC, INC2020-01-03
SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMHOLOGIC, INC2019-11-26
SELENIA MAMMOGRAPHY SYSTEMHOLOGIC, INC2019-11-26
SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMHOLOGIC, INC2019-11-18
SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMHOLOGIC, INC2019-11-13
SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMHOLOGIC, INC2019-11-12
SELENIA MAMMOGRAPHY SYSTEMHOLOGIC, INC2019-11-12
SELENIA MAMMOGRAPHY SYSTEMHOLOGIC, INC2019-11-05
SELENIA MAMMOGRAPHY SYSTEMHOLOGIC, INC2019-11-01
SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMHOLOGIC, INC2019-10-29
SELENIA MAMMOGRAPHY SYSTEMHOLOGIC, INC2019-10-21
SELENIA MAMMOGRAPHY SYSTEMHOLOGIC, INC2019-10-10
SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMHOLOGIC, INC2019-10-02
SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMHOLOGIC, INC2019-09-30
HOLOGIC C VIEW SOFTWARE SYNTHETIC 2D MAMMOGRAM SOFTWAREHOLOGIC, INC.2019-09-23
SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMHOLOGIC, INC2019-08-30
HOLOGIC SELENIAHOLOGIC, INC.2019-08-28
SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMHOLOGIC, INC2019-08-28
SELENIA MAMMOGRAPHY SYSTEMHOLOGIC, INC2019-08-23
SELENIA MAMMOGRAPHY SYSTEMHOLOGIC, INC2019-08-22
SELENIA MAMMOGRAPHY SYSTEMHOLOGIC, INC2019-08-08
SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMHOLOGIC, INC2019-08-07
SELENIA MAMMOGRAPHY SYSTEMHOLOGIC, INC2019-08-05
MAMMOMAT REVELATIONSIEMENS HEALTHCARE GMBH2019-08-01
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