Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
GE Healthcare · Predicate Candidate Screening
168 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
58 daysmedian FDA review time
166 days90th percentile
168clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253639 | View | GE Healthcare | 2026-01-08 | 50 | 0 |
| K242925 | MR Contour DL | GE Healthcare | 2025-04-01 | 189 | 0 |
| K232346 | Digital Expert Access with Remote Scanning | GE Healthcare | 2023-10-27 | 84 | 0 |
| K223212 | Precision DL | GE Healthcare | 2023-04-27 | 192 | 0 |
| K221680 | Xeleris V Processing and Review System | GE Healthcare | 2023-03-01 | 265 | 0 |
| K221932 | Omni Legend | GE Healthcare | 2022-09-02 | 63 | 1 |
| K213689 | Voluson P6, Voluson P8 | GE Healthcare | 2022-02-17 | 86 | 0 |
| K213642 | Voluson S6, Voluson S8, Voluson S8t, Voluson S10, Voluson S1 | GE Healthcare | 2022-01-13 | 56 | 0 |
| K211488 | LOGIQ E10 | GE Healthcare | 2021-09-10 | 120 | 0 |
| K211524 | LOGIQ E10s, LOGIQ Fortis | GE Healthcare | 2021-08-27 | 102 | 0 |
| K212004 | MyoSPECT, MyoSpect ES | GE Healthcare | 2021-08-27 | 60 | 1 |
| K211725 | Senographe Pristina | GE Healthcare | 2021-08-06 | 63 | 0 |
| K211215 | SenoBright HD | GE Healthcare | 2021-06-22 | 60 | 1 |
| K211312 | Universal Viewer | GE Healthcare | 2021-05-21 | 21 | 2 |
| K210173 | StarGuide | GE Healthcare | 2021-03-29 | 66 | 0 |
| K201628 | Panda iRes Warmer, Giraffe Warmer | GE Healthcare | 2021-02-12 | 241 | 3 |
| K201768 | Voluson E10 | GE Healthcare | 2020-10-22 | 115 | 0 |
| K201103 | Xeleris V Processing and Review Systems | GE Healthcare | 2020-09-25 | 154 | 0 |
| K193334 | Pristina Serena Bright | GE Healthcare | 2020-05-15 | 165 | 1 |
| K200494 | CARESCAPE ONE and CARESCAPE DOCK FO, CARESCAPE ECG, CARESCAP | GE Healthcare | 2020-03-29 | 30 | 1 |
| K190008 | Carescape One | GE Healthcare | 2019-12-20 | 352 | 0 |
| K192159 | Voluson E6, Voluson E8, Voluson E10 | GE Healthcare | 2019-08-29 | 20 | 0 |
| K190809 | Sample Imaging for Senographe Pristina | GE Healthcare | 2019-07-29 | 122 | 0 |
| K182951 | Pristina Serena 3D | GE Healthcare | 2019-01-18 | 87 | 2 |
| K182419 | Centricity Universal Viewer | GE Healthcare | 2018-12-14 | 100 | 7 |
| K183116 | Unity Network ID | GE Healthcare | 2018-12-06 | 27 | 0 |
| K181985 | Voluson E6, Voluson E8, Voluson E10 | GE Healthcare | 2018-11-15 | 113 | 1 |
| K181403 | Innova IGS 5, Innova IGS 6, Discovery IGS 7, Discovery IGS 7 | GE Healthcare | 2018-11-02 | 157 | 5 |
| K182590 | 1.5T AIR MP M, 1.5T AIR MP L, 1.5T 16ch AIR AA, 1.5T 30ch AI | GE Healthcare | 2018-10-19 | 29 | 0 |
| K181783 | LOGIQ P9; LOGIQ P7 | GE Healthcare | 2018-09-20 | 79 | 1 |
| K173576 | Pristina Serena | GE Healthcare | 2018-05-14 | 175 | 2 |
| K180641 | Invenia ABUS Viewer | GE Healthcare | 2018-05-04 | 53 | 0 |
| K173816 | NM/CT 850, NM/CT 860 | GE Healthcare | 2018-04-17 | 123 | 3 |
| K180535 | Voluson P6 and Voluson P8 | GE Healthcare | 2018-03-29 | 29 | 1 |
| K180374 | Voluson S8/ Voluson S10/ Voluson S10 Expert | GE Healthcare | 2018-03-13 | 29 | 1 |
| K173555 | LOGIQ E10 | GE Healthcare | 2017-12-20 | 33 | 1 |
| K172404 | SenoBright HD | GE Healthcare | 2017-10-30 | 82 | 0 |
| K172342 | Voluson E6, Voluson E8, Voluson E10 | GE Healthcare | 2017-09-29 | 58 | 0 |
| K163302 | Senographe Pristina | GE Healthcare | 2017-09-01 | 283 | 0 |
| K170199 | Unity Network ID | GE Healthcare | 2017-05-12 | 109 | 0 |
| K170445 | LOGIQ S8 | GE Healthcare | 2017-04-11 | 56 | 1 |
| K163596 | LOGIQ P9 and LOGIQ P7 | GE Healthcare | 2017-02-10 | 51 | 0 |
| K160933 | Discovery NM 750b Bopsy | GE Healthcare | 2016-11-18 | 228 | 0 |
| K162268 | Senographe Pristina | GE Healthcare | 2016-11-03 | 83 | 2 |
| K162269 | Voluson E6, Voluson E8, Voluson E10 | GE Healthcare | 2016-10-03 | 52 | 0 |
| K162012 | CARESCAPE Central Station V2 | GE Healthcare | 2016-09-15 | 56 | 5 |
| K161567 | SIGNA Voyager | GE Healthcare | 2016-09-01 | 86 | 3 |
| K160937 | Senolris | GE Healthcare | 2016-08-01 | 119 | 0 |
| K161047 | LOGIQ P9 and LOGIQ P7 | GE Healthcare | 2016-05-05 | 22 | 0 |
| K160162 | Voluson P6, Voluson P8 | GE Healthcare | 2016-04-26 | 90 | 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