Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
GE Medical Systems Ultrasound and Primary Care Diagnostics · Predicate Candidate Screening
66 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
95 daysmedian FDA review time
154 days90th percentile
66clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261835 | LOGIQ Focus | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2026-07-30 | 58 | 0 |
| K260398 | LOGIQ e | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2026-05-26 | 109 | 0 |
| K260673 | LOGIQ Vita; LOGIQ Vita Pro; LOGIQ Vita Express; LOGIQ Vita P | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2026-03-24 | 22 | 0 |
| K253370 | LOGIQ Totus | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2026-01-08 | 100 | 0 |
| K253366 | LOGIQ Fortis | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2026-01-07 | 99 | 0 |
| K252328 | Voluson Expert 18; Voluson Expert 20; Voluson Expert 22 | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2025-11-24 | 122 | 0 |
| K251963 | LOGIQ E10s | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2025-10-29 | 125 | 0 |
| K251985 | LOGIQ E10 | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2025-10-29 | 124 | 0 |
| K251322 | Venue; Venue Go; Venue Fit; Venue Sprint | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2025-07-25 | 87 | 0 |
| K251342 | EchoPAC Software Only / EchoPAC Plug-in | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2025-07-16 | 77 | 0 |
| K251169 | Vivid Pioneer | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2025-07-10 | 86 | 0 |
| K250543 | Voluson™ Performance 16; Voluson™ Performance 18 | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2025-05-29 | 94 | 0 |
| K250087 | Vscan Air | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2025-05-01 | 107 | 0 |
| K243620 | Vivid iq | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2025-02-11 | 81 | 0 |
| K243628 | Vivid T9/Vivid T8 | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2025-02-11 | 78 | 0 |
| K242168 | Voluson Expert 18; Voluson Expert 20; Voluson Expert 22 | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2024-12-20 | 149 | 0 |
| K242005 | Versana Premier; Versana Premier Lotus; LOGIQ F | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2024-10-02 | 85 | 2 |
| K234106 | Venue Fit | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2024-06-10 | 167 | 1 |
| K240053 | Venue Go | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2024-06-10 | 154 | 1 |
| K240111 | Venue | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2024-06-10 | 146 | 0 |
| K240206 | Venue Sprint | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2024-06-10 | 137 | 0 |
| K233692 | Voluson Signature 20, Voluson Signature 18 | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2024-03-07 | 111 | 0 |
| K232381 | LOGIQ Totus | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2023-12-07 | 121 | 0 |
| K231966 | LOGIQ E10 | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2023-11-07 | 127 | 0 |
| K231965 | Voluson Expert 22, Voluson Expert 20, Voluson Expert 18 | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2023-10-30 | 119 | 0 |
| K231301 | Vscan Air | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2023-08-15 | 102 | 0 |
| K223407 | Versana Essential | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2023-02-15 | 98 | 0 |
| K220940 | EchoPAC Software Only, EchoPAC Plug-in | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2022-07-22 | 113 | 0 |
| K221147 | Vivid T8, Vivid T9 | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2022-07-18 | 89 | 0 |
| K220619 | Vivid S60N, Vivid S70N | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2022-07-15 | 134 | 2 |
| K220800 | Venue Go | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2022-06-21 | 95 | 2 |
| K220358 | Voluson Expert 22, Voluson Expert 20, Voluson Expert 18 | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2022-06-06 | 118 | 0 |
| K220446 | Versana Balance | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2022-05-11 | 84 | 0 |
| K214039 | LOGIQ P10, LOGIQ P9, LOGIQ P8 | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2022-03-22 | 89 | 3 |
| K210438 | Versana Premier | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2021-09-10 | 210 | 0 |
| K211216 | Vivid S60N / Vivid S70N | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2021-06-09 | 47 | 2 |
| K202658 | Vivid E80/ Vivid E90/ Vivid E95 | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2021-03-05 | 172 | 0 |
| K203114 | LOGIQ P10, LOGIQ P9, LOGIQ P8 | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2021-01-08 | 85 | 0 |
| K203137 | Venue Fit | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2020-12-29 | 70 | 1 |
| K202035 | Vscan Air | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2020-11-20 | 120 | 0 |
| K202233 | Venue Go | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2020-11-18 | 103 | 2 |
| K202132 | Venue | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2020-11-13 | 105 | 0 |
| K201828 | Voluson SWIFT, Voluson SWIFT+ | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2020-10-11 | 101 | 0 |
| K200852 | EchoPAC Software Only, EchoPAC Plug-In | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2020-09-18 | 171 | 0 |
| K200851 | Vivid T8, Vivid T9 | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2020-09-09 | 162 | 0 |
| K200497 | Vivid S60N, Vivid S70N | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2020-07-16 | 139 | 2 |
| K200998 | Versana Active | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2020-06-11 | 56 | 0 |
| K200119 | LOGIQ E10s | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2020-04-01 | 71 | 0 |
| K191792 | Versana Balance | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2019-08-09 | 37 | 0 |
| K191798 | Versana Active | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2019-08-09 | 37 | 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