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GE Medical Systems Ultrasound and Primary Care Diagnostics
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 77
- Inspections
- 1
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K254161 | Automated Aortic Stenosis Software (AutoAS) | March 27, 2026 |
| K260673 | LOGIQ Vita; LOGIQ Vita Pro; LOGIQ Vita Express; LOGIQ Vita Plus; LOGIQ Vita Power; LOGIQ S20; LOGIQ | March 24, 2026 |
| K253370 | LOGIQ Totus | January 8, 2026 |
| K253366 | LOGIQ Fortis | January 7, 2026 |
| K252328 | Voluson Expert 18; Voluson Expert 20; Voluson Expert 22 | November 24, 2025 |
| K251985 | LOGIQ E10 | October 29, 2025 |
| K251963 | LOGIQ E10s | October 29, 2025 |
| K251322 | Venue; Venue Go; Venue Fit; Venue Sprint | July 25, 2025 |
| K251342 | EchoPAC Software Only / EchoPAC Plug-in | July 16, 2025 |
| K251169 | Vivid Pioneer | July 10, 2025 |
| K250543 | Voluson Performance 16; Voluson Performance 18 | May 29, 2025 |
| K250087 | Vscan Air | May 1, 2025 |
| K243628 | Vivid T9/Vivid T8 | February 11, 2025 |
| K243620 | Vivid iq | February 11, 2025 |
| K242168 | Voluson Expert 18; Voluson Expert 20; Voluson Expert 22 | December 20, 2024 |
| K242005 | Versana Premier; Versana Premier Lotus; LOGIQ F | October 2, 2024 |
| K240111 | Venue | June 10, 2024 |
| K234106 | Venue Fit | June 10, 2024 |
| K240053 | Venue Go | June 10, 2024 |
| K240206 | Venue Sprint | June 10, 2024 |