Product Code: MUE FDA class 2 21 CFR 892.1715

Full Field Digital, System, X-Ray, Mammographic

Radiology

A Full Field Digital Mammographic X-Ray System is a specialized radiographic imaging system that captures digital X-ray images of the entire breast for breast cancer screening and diagnosis, replacing traditional film-based mammography with digital detectors for improved image quality and processing flexibility. It is FDA Class 2, requiring 510(k) clearance, with product code MUE under 21 CFR 892.1715 in the Radiology specialty. The device is not an implant and is not life-sustaining.

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FEI Numbers

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Basic Information

Product Code: MUE
Device Class: FDA class 2
Regulation Number: 892.1715
Medical Specialty: Radiology
Review Panel: RA
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 55 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K253678	MAMMOMAT B.brilliant (11372950)	Jun 18, 2026	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K254092	Bellalun 2D (VDMS-1000S)	May 28, 2026	Substantially Equivalent	Vieworks Co., Ltd.
K260087	Senographe Pristina; SenoBright HD; Pristina Serena; Pristina Serena Bright	Mar 24, 2026	Substantially Equivalent	GE Medical Systems SCS
K243420	HESTIA	Jul 17, 2025	Substantially Equivalent	Genoray Co., Ltd.
K243849	2430TCA with Xmaru W	Mar 12, 2025	Substantially Equivalent	Rayence Co., Ltd.
K241113	VIVIX-M	Jan 16, 2025	Substantially Equivalent	Vieworks Co., Ltd.
K233539	MAMMOMAT B.brilliant	Mar 27, 2024	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K220073	RMF-2000	Jan 26, 2023	Substantially Equivalent	DRTECH Corporation
K211720	Planmed Clarity 2D, Planmed Clarify S	Jul 18, 2022	Substantially Equivalent	Planmed OY
K212873	Aspire Cristalle	May 27, 2022	Substantially Equivalent	Fujifilm Corporation
K210151	Digimamo D	Mar 01, 2022	Substantially Equivalent	Vmi Tecnologias Ltda
K202822	Helianthus	Dec 15, 2021	Substantially Equivalent	Metaltronica Spa
K211725	Senographe Pristina	Aug 06, 2021	Substantially Equivalent	GE Healthcare
K211215	SenoBright HD	Jun 22, 2021	Substantially Equivalent	GE Healthcare
K202902	2430MCA with Xmaru W	Jun 21, 2021	Substantially Equivalent	Rayence Co., Ltd.
K192317	Planmed Clarity 2D and Clarity S	Oct 23, 2020	Substantially Equivalent	Planmed OY
K200424	Giotto Class (Models - 3000X-YY and 4000X-YY)	Jun 18, 2020	Substantially Equivalent	Ims Giotto S.P.A.
K193166	MAMMOMAT Revelation	Jun 12, 2020	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K193334	Pristina Serena Bright	May 15, 2020	Substantially Equivalent	GE Healthcare
K190809	Sample Imaging for Senographe Pristina	Jul 29, 2019	Substantially Equivalent	GE Healthcare
K182951	Pristina Serena 3D	Jan 18, 2019	Substantially Equivalent	GE Healthcare
K173576	Pristina Serena	May 14, 2018	Substantially Equivalent	GE Healthcare
K173408	Mammomat Revelation	Mar 21, 2018	Substantially Equivalent	Siemens Medi Cal Solutions, Inc.
K163328	Planmed Clarity	Dec 28, 2017	Substantially Equivalent	Planmed OY
K172404	SenoBright HD	Oct 30, 2017	Substantially Equivalent	GE Healthcare
K173132	ASPIRE Cristalle	Oct 27, 2017	Substantially Equivalent	Fujifilm Medical Systems U.S.A, Inc.
K172027	Adani MammoScan	Oct 20, 2017	Substantially Equivalent	Adani
K163302	Senographe Pristina	Sep 01, 2017	Substantially Equivalent	GE Healthcare
K170930	RSM 2430C	Apr 27, 2017	Substantially Equivalent	DRTECH Corporation
K162670	RSM 1824C with RConsole1	Feb 23, 2017	Substantially Equivalent	DRTECH Corporation
K163252	Mammomat Fusion with Stereotactic Biopsy	Jan 10, 2017	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K162268	Senographe Pristina	Nov 03, 2016	Substantially Equivalent	GE Healthcare
K151645	MAMMOMAT Fusion	Sep 14, 2015	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K133972	ASPIRE CRISTALLE	Mar 25, 2014	Substantially Equivalent	Fujifilm Medical Systems U.S.A, Inc.
K130704	MICRODOSE SI	Dec 13, 2013	Substantially Equivalent	Philips Digital Mammography Sweden AB
K131885	SENOGRAPHE ESSENTIAL, PREMIUM VIEW I (PVI)	Sep 26, 2013	Substantially Equivalent	GE Medical Systems SCS
K123520	MAMMOMAT INSPIRATION PRIME	Jun 11, 2013	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K122510	ICRCO 3600M	Apr 26, 2013	Substantially Equivalent	Icrco, Inc.
K122286	MAMMOMAL INSPIRATION	Feb 22, 2013	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K123995	MICRODOSE SI	Feb 01, 2013	Substantially Equivalent	Philips Digital Mammography Sweden AB
K123873	CONTRAST ENHANCED DIGITAL MAMMOGRAPHY	Jan 29, 2013	Substantially Equivalent	Hologic, Inc.
K121963	PLANMED NUANCE DIGIGUIDE	Nov 21, 2012	Substantially Equivalent	Planmed OY
K121674	ASPIRE HD PLUS, ASPIRE HD-S	Sep 21, 2012	Substantially Equivalent	Fujifilm Medical System U.S.A., Inc.
K120246	KODAK DIRECTVIEW CR MAMMOGRAPHY SYSTEM (USING CARESTREAM CR MAMMOGRAPHY CASSETTE WITH SNP-M1 SCREEN)	Aug 28, 2012	Substantially Equivalent	Carestream Health, Inc.
K120255	PHILIPS MICRODOSE	Apr 19, 2012	Substantially Equivalent	Philips Digital Mammography Sweden AB
K110717	KONICA MINOLTA XPRESS DIGITAL MAMMOGRAPHY SYSTEM	Dec 23, 2011	Substantially Equivalent	Konica Minolta Medical & Graphic, Inc.
K111324	CR MAMMOGRAPHY SYSTEM WITH DX-M DIGITIZER	Dec 22, 2011	Substantially Equivalent	Agfa Healthcare N.V.
K110798	SENOGRAPHE DS, SENOGRAPHE ESSENTIAL	Dec 22, 2011	Substantially Equivalent	General Electric Company
K111646	ASPIRE CR FOR MAMMOGRAPHY SYSTEM (CRM); FCR ASPIRE CRN (READER). NOTE FOR GENERAL RADIOGRAPHY, READER IS CARBON XL2/FCR	Dec 08, 2011	Substantially Equivalent	Fujifilm Medical System U.S.A., Inc.
K111434	GIOTTO IMAGE 3D, GIOTTO IMAGE 3D-L	Oct 27, 2011	Substantially Equivalent	Giotto USA, LLC
K103485	SENOGRAPH DS, SENOGRAPH ESSENSTIAL	Oct 06, 2011	Substantially Equivalent	General Electric Company
K111361	PLANMED NUANCE EXCEL	Sep 23, 2011	Substantially Equivalent	Planmeca USA, Inc.
K110572	MAMMODIAGNOST DR	Sep 23, 2011	Substantially Equivalent	Philips Medical Systems
K110729	ASPIRE HD FULL-FIELD DIGITAL MAMMOGRAPHY SYSTEM	Sep 01, 2011	Substantially Equivalent	Fujifilm Medical Systems U.S.A, Inc.
K110025	SECTRA MICRODOSE MAMMOGRAPHY	Apr 28, 2011	Substantially Equivalent	Sectra Imtec AB