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 |