Ge Medical Systems, LLC
FDA 510(k) & PMA Approved Devices — 43 products
Total Devices43
Categories9
Latest FDA decision2026-06-24
| Type | Number | Device Name | Code | Date | Actions |
|---|---|---|---|---|---|
| 510(k) | K211118 | SIGNA 7.0T | LNH | 2021-05-13 | View |
| 510(k) | K210982 | AMX Navigate | IZL | 2021-04-28 | View |
| 510(k) | K203617 | MaxFOV 2 | JAK | 2021-03-02 | View |
| 510(k) | K201745 | Deep Learning Image Reconstruction for Gemstone Spectral Imaging | JAK | 2020-12-10 | View |
| 510(k) | K201615 | SIGNA 7.0T | LNH | 2020-10-15 | View |
| 510(k) | K183182 | Critical Care Suite | QFM | 2019-08-12 | View |
| 510(k) | K191777 | Revolution CT, Revolution CT ES, Revolution Apex, Revolution CT with Apex edition | JAK | 2019-07-26 | View |
| 510(k) | K183202 | Deep Learning Image Reconstruction | JAK | 2019-04-12 | View |
| 510(k) | K183161 | SnapShot Freeze 2 | JAK | 2019-02-13 | View |
| 510(k) | K183231 | SIGNA Premier | LNH | 2019-01-18 | View |
| 510(k) | K182234 | Optima XR240amx | IZL | 2018-09-06 | View |
| 510(k) | K180318 | PET Digital Gating | KPS | 2018-04-11 | View |
| 510(k) | K173602 | Optima XR240amx, AutoGrid | IZL | 2018-01-12 | View |
| 510(k) | K171128 | SIGNA Premier | LNH | 2017-07-14 | View |
| 510(k) | K162722 | HyperSense | LNH | 2017-04-20 | View |
| 510(k) | K163331 | Discovery MR750 3.0T; Discovery MR750w 3.0T;Discovery MR450 1.5T; Discovery MR450w 1.5T; SIGNA Architect and SIGNA Artist | LNH | 2017-03-17 | View |
| 510(k) | K163619 | SIGNA PET/MR | OUO | 2017-02-14 | View |
| 510(k) | K163213 | Revolution CT | JAK | 2016-12-16 | View |
| 510(k) | K162403 | HyperBand | LNH | 2016-11-18 | View |
| 510(k) | K162990 | Optima XR240amx | IZL | 2016-11-15 | View |
No matching devices.
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