GE Healthcare
FDA 510(k) & PMA Approved Devices — 57 products
Total Devices57
Categories15
Latest FDA decision2026-01-08
SEC Filings: 1 filings on record. Latest: 8-K (2026-07-29). View on SEC EDGAR →
| Type | Number | Device Name | Code | Date | Actions |
|---|---|---|---|---|---|
| 510(k) | K253639 | View | LLZ | 2026-01-08 | View |
| PMA | P130020 | Digital breast tomosynthesis | OTE | 2025-11-21 | View |
| 510(k) | K242925 | MR Contour DL | QKB | 2025-04-01 | View |
| PMA | P110006 | Automated breast ultrasound | PAA | 2025-02-04 | View |
| 510(k) | K232346 | Digital Expert Access with Remote Scanning | LNH | 2023-10-27 | View |
| 510(k) | K223212 | Precision DL | KPS | 2023-04-27 | View |
| 510(k) | K221680 | Xeleris V Processing and Review System | LLZ | 2023-03-01 | View |
| 510(k) | K221932 | Omni Legend | KPS | 2022-09-02 | View |
| 510(k) | K213689 | Voluson P6, Voluson P8 | IYN | 2022-02-17 | View |
| 510(k) | K213642 | Voluson S6, Voluson S8, Voluson S8t, Voluson S10, Voluson S10 Expert | IYN | 2022-01-13 | View |
| 510(k) | K211488 | LOGIQ E10 | IYN | 2021-09-10 | View |
| 510(k) | K212004 | MyoSPECT, MyoSpect ES | KPS | 2021-08-27 | View |
| 510(k) | K211524 | LOGIQ E10s, LOGIQ Fortis | IYN | 2021-08-27 | View |
| 510(k) | K211725 | Senographe Pristina | MUE | 2021-08-06 | View |
| 510(k) | K211215 | SenoBright HD | MUE | 2021-06-22 | View |
| 510(k) | K211312 | Universal Viewer | LLZ | 2021-05-21 | View |
| 510(k) | K210173 | StarGuide | KPS | 2021-03-29 | View |
| 510(k) | K201628 | Panda iRes Warmer, Giraffe Warmer | FMT | 2021-02-12 | View |
| 510(k) | K201768 | Voluson E10 | IYN | 2020-10-22 | View |
| 510(k) | K201103 | Xeleris V Processing and Review Systems | LLZ | 2020-09-25 | View |
No matching devices.
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