Full Field Digital, System, X-Ray, Mammographic

FDA product code MUE · 54 cleared devices

Class 2 Radiology

Regulation: 21 CFR 892.1715
Review panel: RA
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 2011-04-28 – 2026-09-02

MUE 2026-09-02

I-View®

Applicant Hologic, Inc.

K number K254090

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MUE 2026-06-18

MAMMOMAT B.brilliant (11372950)

Applicant Siemens Medical Solutions USA, Inc.

K number K253678

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MUE 2026-05-28

Bellalun 2D (VDMS-1000S)

Applicant Vieworks Co., Ltd.

K number K254092

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MUE 2026-03-24

Senographe Pristina; SenoBright HD; Pristina Serena; Pristina Serena Bright

Applicant GE Medical Systems SCS

K number K260087

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MUE 2025-07-17

HESTIA

Applicant Genoray Co., Ltd.

K number K243420

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MUE 2025-03-12

2430TCA with Xmaru W

Applicant Rayence Co., Ltd.

K number K243849

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MUE 2025-01-16

VIVIX-M

Applicant Vieworks Co., Ltd.

K number K241113

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MUE 2024-03-27

MAMMOMAT B.brilliant

Applicant Siemens Medical Solutions USA, Inc.

K number K233539

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MUE 2023-01-26

RMF-2000

Applicant DRTECH Corporation

K number K220073

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MUE 2022-07-18

Planmed Clarity 2D, Planmed Clarify S

Applicant Planmed OY

K number K211720

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MUE 2022-05-27

Aspire Cristalle

Applicant Fujifilm Corporation

K number K212873

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MUE 2022-03-01

Digimamo D

Applicant Vmi Tecnologias Ltda

K number K210151

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MUE 2021-12-15

Helianthus

Applicant Metaltronica Spa

K number K202822

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MUE 2021-08-06

Senographe Pristina

Applicant GE Healthcare

K number K211725

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MUE 2021-06-22

SenoBright HD

Applicant GE Healthcare

K number K211215

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MUE 2021-06-21

2430MCA with Xmaru W

Applicant Rayence Co., Ltd.

K number K202902

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MUE 2020-10-23

Planmed Clarity 2D and Clarity S

Applicant Planmed OY

K number K192317

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MUE 2020-06-18

Giotto Class (Models - 3000X-YY and 4000X-YY)

Applicant Ims Giotto S.P.A.

K number K200424

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MUE 2020-06-12

MAMMOMAT Revelation

Applicant Siemens Medical Solutions USA, Inc.

K number K193166

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MUE 2020-05-15

Pristina Serena Bright

Applicant GE Healthcare

K number K193334

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MUE 2019-07-29

Sample Imaging for Senographe Pristina

Applicant GE Healthcare

K number K190809

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MUE 2019-01-18

Pristina Serena 3D

Applicant GE Healthcare

K number K182951

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MUE 2018-05-14

Pristina Serena

Applicant GE Healthcare

K number K173576

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MUE 2018-03-21

Mammomat Revelation

Applicant Siemens Medi Cal Solutions, Inc.

K number K173408

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MUE 2017-12-28

Planmed Clarity

Applicant Planmed OY

K number K163328

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MUE 2017-10-30

SenoBright HD

Applicant GE Healthcare

K number K172404

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MUE 2017-10-27

ASPIRE Cristalle

Applicant Fujifilm Medical Systems U.S.A, Inc.

K number K173132

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MUE 2017-10-20

Adani MammoScan

Applicant Adani

K number K172027

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MUE 2017-09-01

Senographe Pristina

Applicant GE Healthcare

K number K163302

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MUE 2017-04-27

RSM 2430C

Applicant DRTECH Corporation

K number K170930

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MUE 2017-02-23

RSM 1824C with RConsole1

Applicant DRTECH Corporation

K number K162670

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MUE 2017-01-10

Mammomat Fusion with Stereotactic Biopsy

Applicant Siemens Medical Solutions USA, Inc.

K number K163252

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MUE 2016-11-03

Senographe Pristina

Applicant GE Healthcare

K number K162268

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MUE 2013-12-13

MICRODOSE SI

Applicant Philips Digital Mammography Sweden AB

K number K130704

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MUE 2013-09-26

SENOGRAPHE ESSENTIAL, PREMIUM VIEW I (PVI)

Applicant GE Medical Systems SCS

K number K131885

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MUE 2013-06-11

MAMMOMAT INSPIRATION PRIME

Applicant Siemens Medical Solutions USA, Inc.

K number K123520

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MUE 2013-04-26

ICRCO 3600M

Applicant Icrco, Inc.

K number K122510

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MUE 2013-02-22

MAMMOMAL INSPIRATION

Applicant Siemens Medical Solutions USA, Inc.

K number K122286

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MUE 2013-02-01

MICRODOSE SI

Applicant Philips Digital Mammography Sweden AB

K number K123995

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MUE 2013-01-29

CONTRAST ENHANCED DIGITAL MAMMOGRAPHY

Applicant Hologic, Inc.

K number K123873

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MUE 2012-11-21

PLANMED NUANCE DIGIGUIDE

Applicant Planmed OY

K number K121963

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MUE 2012-09-21

ASPIRE HD PLUS, ASPIRE HD-S

Applicant Fujifilm Medical System U.S.A., Inc.

K number K121674

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MUE 2012-08-28

KODAK DIRECTVIEW CR MAMMOGRAPHY SYSTEM (USING CARESTREAM CR MAMMOGRAPHY CASSETTE WITH SNP-M1 SCREEN)

Applicant Carestream Health, Inc.

K number K120246

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MUE 2012-04-19

PHILIPS MICRODOSE

Applicant Philips Digital Mammography Sweden AB

K number K120255

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MUE 2011-12-23

KONICA MINOLTA XPRESS DIGITAL MAMMOGRAPHY SYSTEM

Applicant Konica Minolta Medical & Graphic, Inc.

K number K110717

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MUE 2011-12-22

CR MAMMOGRAPHY SYSTEM WITH DX-M DIGITIZER

Applicant Agfa Healthcare N.V.

K number K111324

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MUE 2011-12-22

SENOGRAPHE DS, SENOGRAPHE ESSENTIAL

Applicant General Electric Company

K number K110798

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MUE 2011-12-08

ASPIRE CR FOR MAMMOGRAPHY SYSTEM (CRM); FCR ASPIRE CRN (READER). NOTE FOR GENERAL RADIOGRAPHY, READER IS CARBON XL2/FCR

Applicant Fujifilm Medical System U.S.A., Inc.

K number K111646

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MUE 2011-10-27

GIOTTO IMAGE 3D, GIOTTO IMAGE 3D-L

Applicant Giotto USA, LLC

K number K111434

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MUE 2011-10-06

SENOGRAPH DS, SENOGRAPH ESSENSTIAL

Applicant General Electric Company

K number K103485

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MUE 2011-09-23

PLANMED NUANCE EXCEL

Applicant Planmeca USA, Inc.

K number K111361

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MUE 2011-09-23

MAMMODIAGNOST DR

Applicant Philips Medical Systems

K number K110572

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MUE 2011-09-01

ASPIRE HD FULL-FIELD DIGITAL MAMMOGRAPHY SYSTEM

Applicant Fujifilm Medical Systems U.S.A, Inc.

K number K110729

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MUE 2011-04-28

SECTRA MICRODOSE MAMMOGRAPHY

Applicant Sectra Imtec AB

K number K110025

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