Allia IGS 3, Allia IGS 5, Allia IGS 7, Allia IGS 7 OR
FDA 510(k) clearance K232344 · decided 2023-10-11
Clearance details
- K-number
- K232344
- Device name
- Allia IGS 3, Allia IGS 5, Allia IGS 7, Allia IGS 7 OR
- Applicant
- GE Medical Systems SCS
- Decision
- Substantially Equivalent
- Date received
- 2023-08-04
- Decision date
- 2023-10-11
- Days to decision
- 68 days
- Clearance type
- Special
- Product code
- OWB
- Device class
- 2
- Regulation number
- 892.1650
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Buc, FR
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Allia IGS 3 Pulse angiographic X-ray system recall (Z-2314-2026) | GE Medical Systems, LLC | 2026-06-05 |
| Allia IGS 5 Pulse angiographic X-ray system recall (Z-2315-2026) | GE Medical Systems, LLC | 2026-06-05 |
| Allia IGS 7 Pulse angiographic X-ray system recall (Z-2316-2026) | GE Medical Systems, LLC | 2026-06-05 |
| Allia IGS Pulse angiographic X-ray system recall (Z-2317-2026) | GE Medical Systems, LLC | 2026-06-05 |
| GE Healthcare Interact Discovery RT, Interventional fluoroscopic x-ray systems recall (Z-1779-2024) | GE Medical Systems, SCS | 2024-05-06 |
| GE Healthcare Allia IGS 7, Interventional fluoroscopic x-ray systems recall (Z-1780-2024) | GE Medical Systems, SCS | 2024-05-06 |
| GE Healthcare Allia IGS 7 OR, Interventional fluoroscopic x-ray systems recall (Z-1781-2024) | GE Medical Systems, SCS | 2024-05-06 |