FDA 510(k) Applications for Medical Device Product Code "MUE"
(Full Field Digital,System,X-Ray,Mammographic)

FDA 510(k) Number Applicant Device Name Decision Date
K172027 ADANI Adani MammoScan 10/20/2017
K111324 AGFA HEALTHCARE N.V. CR MAMMOGRAPHY SYSTEM WITH DX-M DIGITIZER 12/22/2011
K120246 CARESTREAM HEALTH,INC. KODAK DIRECTVIEW CR MAMMOGRAPHY SYSTEM (USING CARESTREAM CR MAMMOGRAPHY CASSETTE WITH SNP-M1 SCREEN) 08/28/2012
K220073 DRTECH Corporation RMF-2000 01/26/2023
K162670 DRTECH CORPORATION RSM 1824C with RConsole1 02/23/2017
K170930 DRTECH Corporation RSM 2430C 04/27/2017
K212873 FUJIFILM Corporation Aspire Cristalle 05/27/2022
K111646 FUJIFILM MEDICAL SYSTEM U.S.A., INC. ASPIRE CR FOR MAMMOGRAPHY SYSTEM (CRM); FCR ASPIRE CRN (READER). NOTE FOR GENERAL RADIOGRAPHY, READER IS CARBON XL2/FCR 12/08/2011
K121674 FUJIFILM MEDICAL SYSTEM U.S.A., INC. ASPIRE HD PLUS, ASPIRE HD-S 09/21/2012
K173132 Fujifilm Medical Systems U.S.A., Inc. ASPIRE Cristalle 10/27/2017
K133972 FUJIFILM MEDICAL SYSTEMS, USA INC. ASPIRE CRISTALLE 03/25/2014
K110729 FUJIFILM MEDICAL SYSTEMS, USA INC. ASPIRE HD FULL-FIELD DIGITAL MAMMOGRAPHY SYSTEM 09/01/2011
K173576 GE Healthcare Pristina Serena 05/14/2018
K182951 GE Healthcare Pristina Serena 3D 01/18/2019
K193334 GE Healthcare Pristina Serena Bright 05/15/2020
K190809 GE Healthcare Sample Imaging for Senographe Pristina 07/29/2019
K172404 GE Healthcare SenoBright HD 10/30/2017
K211215 GE Healthcare SenoBright HD 06/22/2021
K211725 GE Healthcare Senographe Pristina 08/06/2021
K162268 GE HEALTHCARE Senographe Pristina 11/03/2016
K163302 GE Healthcare Senographe Pristina 09/01/2017
K131885 GE MEDICAL SYSTEMS SCS SENOGRAPHE ESSENTIAL, PREMIUM VIEW I (PVI) 09/26/2013
K103485 GENERAL ELECTRIC COMPANY SENOGRAPH DS, SENOGRAPH ESSENSTIAL 10/06/2011
K110798 GENERAL ELECTRIC COMPANY SENOGRAPHE DS, SENOGRAPHE ESSENTIAL 12/22/2011
K111434 GIOTTO USA, LLC GIOTTO IMAGE 3D, GIOTTO IMAGE 3D-L 10/27/2011
K123873 HOLOGIC, INC. CONTRAST ENHANCED DIGITAL MAMMOGRAPHY 01/29/2013
K122510 ICRCO INC. ICRCO 3600M 04/26/2013
K200424 IMS GIOTTO S.p.A. Giotto Class (Models - 3000X-YY and 4000X-YY) 06/18/2020
K110717 KONICA MINOLTA MEDICAL & GRAPHIC, INC. KONICA MINOLTA XPRESS DIGITAL MAMMOGRAPHY SYSTEM 12/23/2011
K202822 Metaltronica Spa Helianthus 12/15/2021
K123995 PHILIPS DIGITAL MAMMOGRAPHY SWEDEN AB MICRODOSE SI 02/01/2013
K130704 PHILIPS DIGITAL MAMMOGRAPHY SWEDEN AB MICRODOSE SI 12/13/2013
K120255 PHILIPS DIGITAL MAMMOGRAPHY SWEDEN AB PHILIPS MICRODOSE 04/19/2012
K110572 PHILIPS MEDICAL SYSTEMS MAMMODIAGNOST DR 09/23/2011
K111361 PLANMECA USA, INC. PLANMED NUANCE EXCEL 09/23/2011
K163328 Planmed Oy Planmed Clarity 12/28/2017
K192317 Planmed Oy Planmed Clarity 2D and Clarity S 10/23/2020
K211720 Planmed Oy Planmed Clarity 2D, Planmed Clarify S 07/18/2022
K121963 PLANMED OY PLANMED NUANCE DIGIGUIDE 11/21/2012
K202902 Rayence Co., Ltd 2430MCA with Xmaru W 06/21/2021
K110025 SECTRA IMTEC AB SECTRA MICRODOSE MAMMOGRAPHY 04/28/2011
K163252 SIEMENS MEDICAL SOLUTIONS USA, INC Mammomat Fusion with Stereotactic Biopsy 01/10/2017
K122286 SIEMENS MEDICAL SOLUTIONS USA, INC. MAMMOMAL INSPIRATION 02/22/2013
K151645 Siemens Medical Solutions USA, Inc. MAMMOMAT Fusion 09/14/2015
K123520 SIEMENS MEDICAL SOLUTIONS USA, INC. MAMMOMAT INSPIRATION PRIME 06/11/2013
K193166 Siemens Medical Solutions USA, Inc. MAMMOMAT Revelation 06/12/2020
K173408 Siemens Medical Solutions, Inc. Mammomat Revelation 03/21/2018
K210151 VMI Tecnologias LTDA Digimamo D 03/01/2022


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