Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
MUE — Predicate Candidate Screening
55 FDA 510(k) clearances under this product code; the 50 most recent screened below.
160 daysmedian FDA review time
381 days90th percentile
55clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253678 | MAMMOMAT B.brilliant (11372950) | Siemens Medical Solutions USA, Inc. | 2026-06-18 | 209 | 0 |
| K254092 | Bellalun 2D (VDMS-1000S) | Vieworks Co., Ltd. | 2026-05-28 | 160 | 0 |
| K260087 | Senographe Pristina; SenoBright HD; Pristina Serena; Pristin | GE Medical Systems SCS | 2026-03-24 | 71 | 0 |
| K243420 | HESTIA | Genoray Co., Ltd. | 2025-07-17 | 255 | 0 |
| K243849 | 2430TCA with Xmaru W | Rayence Co., Ltd. | 2025-03-12 | 86 | 0 |
| K241113 | VIVIX-M | Vieworks Co., Ltd. | 2025-01-16 | 269 | 0 |
| K233539 | MAMMOMAT B.brilliant | Siemens Medical Solutions USA, Inc. | 2024-03-27 | 145 | 0 |
| K220073 | RMF-2000 | DRTECH Corporation | 2023-01-26 | 381 | 0 |
| K211720 | Planmed Clarity 2D, Planmed Clarify S | Planmed OY | 2022-07-18 | 409 | 0 |
| K212873 | Aspire Cristalle | Fujifilm Corporation | 2022-05-27 | 260 | 0 |
| K210151 | Digimamo D | Vmi Tecnologias Ltda | 2022-03-01 | 404 | 0 |
| K202822 | Helianthus | Metaltronica Spa | 2021-12-15 | 447 | 0 |
| K211725 | Senographe Pristina | GE Healthcare | 2021-08-06 | 63 | 0 |
| K211215 | SenoBright HD | GE Healthcare | 2021-06-22 | 60 | 1 |
| K202902 | 2430MCA with Xmaru W | Rayence Co., Ltd. | 2021-06-21 | 265 | 0 |
| K192317 | Planmed Clarity 2D and Clarity S | Planmed OY | 2020-10-23 | 424 | 0 |
| K200424 | Giotto Class (Models - 3000X-YY and 4000X-YY) | Ims Giotto S.P.A. | 2020-06-18 | 119 | 0 |
| K193166 | MAMMOMAT Revelation | Siemens Medical Solutions USA, Inc. | 2020-06-12 | 210 | 1 |
| K193334 | Pristina Serena Bright | GE Healthcare | 2020-05-15 | 165 | 1 |
| K190809 | Sample Imaging for Senographe Pristina | GE Healthcare | 2019-07-29 | 122 | 0 |
| K182951 | Pristina Serena 3D | GE Healthcare | 2019-01-18 | 87 | 2 |
| K173576 | Pristina Serena | GE Healthcare | 2018-05-14 | 175 | 2 |
| K173408 | Mammomat Revelation | Siemens Medi Cal Solutions, Inc. | 2018-03-21 | 140 | 1 |
| K163328 | Planmed Clarity | Planmed OY | 2017-12-28 | 395 | 0 |
| K172404 | SenoBright HD | GE Healthcare | 2017-10-30 | 82 | 0 |
| K173132 | ASPIRE Cristalle | Fujifilm Medical Systems U.S.A, Inc. | 2017-10-27 | 28 | 0 |
| K172027 | Adani MammoScan | Adani | 2017-10-20 | 107 | 0 |
| K163302 | Senographe Pristina | GE Healthcare | 2017-09-01 | 283 | 0 |
| K170930 | RSM 2430C | DRTECH Corporation | 2017-04-27 | 29 | 0 |
| K162670 | RSM 1824C with RConsole1 | DRTECH Corporation | 2017-02-23 | 150 | 0 |
| K163252 | Mammomat Fusion with Stereotactic Biopsy | Siemens Medical Solutions USA, Inc. | 2017-01-10 | 53 | 0 |
| K162268 | Senographe Pristina | GE Healthcare | 2016-11-03 | 83 | 2 |
| K151645 | MAMMOMAT Fusion | Siemens Medical Solutions USA, Inc. | 2015-09-14 | 88 | 1 |
| K133972 | ASPIRE CRISTALLE | Fujifilm Medical Systems U.S.A, Inc. | 2014-03-25 | 89 | 1 |
| K130704 | MICRODOSE SI | Philips Digital Mammography Sweden AB | 2013-12-13 | 273 | 0 |
| K131885 | SENOGRAPHE ESSENTIAL, PREMIUM VIEW I (PVI) | GE Medical Systems SCS | 2013-09-26 | 93 | 0 |
| K123520 | MAMMOMAT INSPIRATION PRIME | Siemens Medical Solutions USA, Inc. | 2013-06-11 | 208 | 1 |
| K122510 | ICRCO 3600M | Icrco, Inc. | 2013-04-26 | 252 | 0 |
| K122286 | MAMMOMAL INSPIRATION | Siemens Medical Solutions USA, Inc. | 2013-02-22 | 207 | 4 |
| K123995 | MICRODOSE SI | Philips Digital Mammography Sweden AB | 2013-02-01 | 37 | 0 |
| K123873 | CONTRAST ENHANCED DIGITAL MAMMOGRAPHY | Hologic, Inc. | 2013-01-29 | 43 | 0 |
| K121963 | PLANMED NUANCE DIGIGUIDE | Planmed OY | 2012-11-21 | 139 | 0 |
| K121674 | ASPIRE HD PLUS, ASPIRE HD-S | Fujifilm Medical System U.S.A., Inc. | 2012-09-21 | 107 | 1 |
| K120246 | KODAK DIRECTVIEW CR MAMMOGRAPHY SYSTEM (USING CARESTREAM CR | Carestream Health, Inc. | 2012-08-28 | 214 | 0 |
| K120255 | PHILIPS MICRODOSE | Philips Digital Mammography Sweden AB | 2012-04-19 | 83 | 0 |
| K110717 | KONICA MINOLTA XPRESS DIGITAL MAMMOGRAPHY SYSTEM | Konica Minolta Medical & Graphic, Inc. | 2011-12-23 | 283 | 0 |
| K110798 | SENOGRAPHE DS, SENOGRAPHE ESSENTIAL | General Electric Company | 2011-12-22 | 275 | 0 |
| K111324 | CR MAMMOGRAPHY SYSTEM WITH DX-M DIGITIZER | Agfa Healthcare N.V. | 2011-12-22 | 225 | 0 |
| K111646 | ASPIRE CR FOR MAMMOGRAPHY SYSTEM (CRM); FCR ASPIRE CRN (READ | Fujifilm Medical System U.S.A., Inc. | 2011-12-08 | 178 | 0 |
| K111434 | GIOTTO IMAGE 3D, GIOTTO IMAGE 3D-L | Giotto USA, LLC | 2011-10-27 | 157 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda