Soteria E-View
FDA 510(k) clearance K242488 · decided 2025-01-06
Clearance details
- K-number
- K242488
- Device name
- Soteria E-View
- Applicant
- Omega Medical Imaging, LLC
- Decision
- Substantially Equivalent
- Date received
- 2024-08-21
- Decision date
- 2025-01-06
- Days to decision
- 138 days
- Clearance type
- Traditional
- Product code
- JAA
- Device class
- 2
- Regulation number
- 892.1650
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Sanford, FL, US
- Third-party review
- No
- Expedited review
- No
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| CombiDiagnost R90 (K232910) | Philips Medical Systems Dmc GmbH | 2023-10-19 |
| XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.5 (K232526) | Canon Medical Systems Corporation | 2023-09-12 |
| Nautilus (K220871) | Dornier Medtech America, Inc. | 2022-04-18 |
| Nyquist.IQ (K212890) | Omega Medical Imaging, LLC | 2021-12-13 |
| ProxiDiagnost N90 (K212837) | Philips Medical Systems Dmc GmbH | 2021-09-21 |
| DR 800 with DSA, DR 800 (K212145) | Agfa N.V. | 2021-08-31 |
| Insight Agile DRF (K210469) | Imaging Engineering, LLC | 2021-07-27 |
Recalls involving this device
No recalls on record reference this clearance.