FDA Product Code
FDA Product Code MUE — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Radiology
- 21 CFR Citation
- 892.1715
510(k) Clearances — 56 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K254090 | I-View® | Hologic, Inc. | 2026-09-02 | Traditional | PDF ↗ |
| K253678 | MAMMOMAT B.brilliant (11372950) | Siemens Medical Solutions USA, Inc. | 2026-06-18 | Traditional | PDF ↗ |
| K254092 | Bellalun 2D (VDMS-1000S) | Vieworks Co., Ltd. | 2026-05-28 | Traditional | PDF ↗ |
| K260087 | Senographe Pristina; SenoBright HD; Pristina Serena; Pristina Serena Bright | GE Medical Systems SCS | 2026-03-24 | Traditional | PDF ↗ |
| K243420 | HESTIA | Genoray Co., Ltd. | 2025-07-17 | Traditional | PDF ↗ |
| K243849 | 2430TCA with Xmaru W | Rayence Co., Ltd. | 2025-03-12 | Special | PDF ↗ |
| K241113 | VIVIX-M | Vieworks Co., Ltd. | 2025-01-16 | Traditional | PDF ↗ |
| K233539 | MAMMOMAT B.brilliant | Siemens Medical Solutions USA, Inc. | 2024-03-27 | Traditional | PDF ↗ |
| K220073 | RMF-2000 | DRTECH Corporation | 2023-01-26 | Traditional | PDF ↗ |
| K211720 | Planmed Clarity 2D, Planmed Clarify S | Planmed OY | 2022-07-18 | Traditional | PDF ↗ |
| K212873 | Aspire Cristalle | Fujifilm Corporation | 2022-05-27 | Traditional | PDF ↗ |
| K210151 | Digimamo D | Vmi Tecnologias Ltda | 2022-03-01 | Traditional | PDF ↗ |
| K202822 | Helianthus | Metaltronica Spa | 2021-12-15 | Traditional | PDF ↗ |
| K211725 | Senographe Pristina | GE Healthcare | 2021-08-06 | Traditional | PDF ↗ |
| K211215 | SenoBright HD | GE Healthcare | 2021-06-22 | Traditional | PDF ↗ |
| K202902 | 2430MCA with Xmaru W | Rayence Co., Ltd. | 2021-06-21 | Traditional | PDF ↗ |
| K192317 | Planmed Clarity 2D and Clarity S | Planmed OY | 2020-10-23 | Traditional | PDF ↗ |
| K200424 | Giotto Class (Models - 3000X-YY and 4000X-YY) | Ims Giotto S.P.A. | 2020-06-18 | Special | PDF ↗ |
| K193166 | MAMMOMAT Revelation | Siemens Medical Solutions USA, Inc. | 2020-06-12 | Traditional | PDF ↗ |
| K193334 | Pristina Serena Bright | GE Healthcare | 2020-05-15 | Traditional | PDF ↗ |
| K190809 | Sample Imaging for Senographe Pristina | GE Healthcare | 2019-07-29 | Traditional | PDF ↗ |
| K182951 | Pristina Serena 3D | GE Healthcare | 2019-01-18 | Traditional | PDF ↗ |
| K173576 | Pristina Serena | GE Healthcare | 2018-05-14 | Traditional | PDF ↗ |
| K173408 | Mammomat Revelation | Siemens Medi Cal Solutions, Inc. | 2018-03-21 | Traditional | PDF ↗ |
| K163328 | Planmed Clarity | Planmed OY | 2017-12-28 | Traditional | PDF ↗ |
| K172404 | SenoBright HD | GE Healthcare | 2017-10-30 | Traditional | PDF ↗ |
| K173132 | ASPIRE Cristalle | Fujifilm Medical Systems U.S.A, Inc. | 2017-10-27 | Special | PDF ↗ |
| K172027 | Adani MammoScan | Adani | 2017-10-20 | Traditional | PDF ↗ |
| K163302 | Senographe Pristina | GE Healthcare | 2017-09-01 | Traditional | PDF ↗ |
| K170930 | RSM 2430C | DRTECH Corporation | 2017-04-27 | Special | PDF ↗ |
| K162670 | RSM 1824C with RConsole1 | DRTECH Corporation | 2017-02-23 | Traditional | PDF ↗ |
| K163252 | Mammomat Fusion with Stereotactic Biopsy | Siemens Medical Solutions USA, Inc. | 2017-01-10 | Traditional | PDF ↗ |
| K162268 | Senographe Pristina | GE Healthcare | 2016-11-03 | Traditional | PDF ↗ |
| K151645 | MAMMOMAT Fusion | Siemens Medical Solutions USA, Inc. | 2015-09-14 | Traditional | PDF ↗ |
| K133972 | ASPIRE CRISTALLE | Fujifilm Medical Systems U.S.A, Inc. | 2014-03-25 | Traditional | PDF ↗ |
| K130704 | MICRODOSE SI | Philips Digital Mammography Sweden AB | 2013-12-13 | Traditional | PDF ↗ |
| K131885 | SENOGRAPHE ESSENTIAL, PREMIUM VIEW I (PVI) | GE Medical Systems SCS | 2013-09-26 | Traditional | PDF ↗ |
| K123520 | MAMMOMAT INSPIRATION PRIME | Siemens Medical Solutions USA, Inc. | 2013-06-11 | Traditional | PDF ↗ |
| K122510 | ICRCO 3600M | Icrco, Inc. | 2013-04-26 | Traditional | PDF ↗ |
| K122286 | MAMMOMAL INSPIRATION | Siemens Medical Solutions USA, Inc. | 2013-02-22 | Traditional | PDF ↗ |
| K123995 | MICRODOSE SI | Philips Digital Mammography Sweden AB | 2013-02-01 | Special | PDF ↗ |
| K123873 | CONTRAST ENHANCED DIGITAL MAMMOGRAPHY | Hologic, Inc. | 2013-01-29 | Traditional | PDF ↗ |
| K121963 | PLANMED NUANCE DIGIGUIDE | Planmed OY | 2012-11-21 | Traditional | PDF ↗ |
| K121674 | ASPIRE HD PLUS, ASPIRE HD-S | Fujifilm Medical System U.S.A., Inc. | 2012-09-21 | Traditional | PDF ↗ |
| K120246 | KODAK DIRECTVIEW CR MAMMOGRAPHY SYSTEM (USING CARESTREAM CR MAMMOGRAPHY CASSETTE WITH SNP-M1 SCREEN) | Carestream Health, Inc. | 2012-08-28 | Traditional | PDF ↗ |
| K120255 | PHILIPS MICRODOSE | Philips Digital Mammography Sweden AB | 2012-04-19 | Traditional | PDF ↗ |
| K110717 | KONICA MINOLTA XPRESS DIGITAL MAMMOGRAPHY SYSTEM | Konica Minolta Medical & Graphic, Inc. | 2011-12-23 | Traditional | PDF ↗ |
| K110798 | SENOGRAPHE DS, SENOGRAPHE ESSENTIAL | General Electric Company | 2011-12-22 | Traditional | PDF ↗ |
| K111324 | CR MAMMOGRAPHY SYSTEM WITH DX-M DIGITIZER | Agfa Healthcare N.V. | 2011-12-22 | Traditional | PDF ↗ |
| K111646 | ASPIRE CR FOR MAMMOGRAPHY SYSTEM (CRM); FCR ASPIRE CRN (READER). NOTE FOR GENERAL RADIOGRAPHY, READER IS CARBON XL2/FCR | Fujifilm Medical System U.S.A., Inc. | 2011-12-08 | Traditional | PDF ↗ |
| K111434 | GIOTTO IMAGE 3D, GIOTTO IMAGE 3D-L | Giotto USA, LLC | 2011-10-27 | Traditional | PDF ↗ |
| K103485 | SENOGRAPH DS, SENOGRAPH ESSENSTIAL | General Electric Company | 2011-10-06 | Traditional | PDF ↗ |
| K111361 | PLANMED NUANCE EXCEL | Planmeca USA, Inc. | 2011-09-23 | Traditional | PDF ↗ |
| K110572 | MAMMODIAGNOST DR | Philips Medical Systems | 2011-09-23 | Traditional | PDF ↗ |
| K110729 | ASPIRE HD FULL-FIELD DIGITAL MAMMOGRAPHY SYSTEM | Fujifilm Medical Systems U.S.A, Inc. | 2011-09-01 | Traditional | PDF ↗ |
| K110025 | SECTRA MICRODOSE MAMMOGRAPHY | Sectra Imtec AB | 2011-04-28 | Traditional | PDF ↗ |
Product code MUE · Class II · Radiology. Data: openFDA.