Allia IGS 3, Allia IGS 5, Allia IGS 7, Allia IGS 7 OR— 510(k) K232344
Substantially EquivalentGE Medical Systems SCS
FDA 510(k) clearance K232344 for Allia IGS 3, Allia IGS 5, Allia IGS 7, Allia IGS 7 OR, Substantially Equivalent on 2023-10-11. Applicant: GE Medical Systems SCS. Device class: 2.
Clearance details
- Applicant
- GE Medical Systems SCS
- Product code
- Code OWB
- Device class
- Class 2
- Regulation
- 21 CFR 892.1650
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Buc, FR
Recent devices under product code OWB
view allMore clearances from GE Medical Systems SCS
view allAdverse events under product code OWB
product code OWB- Death
- 49
- Injury
- 340
- Malfunction
- 36,973
- Total
- 37,362
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K232344
K-number listed on FDA's recall record- Z-2314-2026 — Allia IGS 3 Pulse angiographic X-ray system
- Z-2315-2026 — Allia IGS 5 Pulse angiographic X-ray system
- Z-2316-2026 — Allia IGS 7 Pulse angiographic X-ray system
- Z-2317-2026 — Allia IGS Pulse angiographic X-ray system
- Z-1779-2024 — GE Healthcare Interact Discovery RT, Interventional fluoroscopic x-ray systems
- Z-1780-2024 — GE Healthcare Allia IGS 7, Interventional fluoroscopic x-ray systems
- Z-1781-2024 — GE Healthcare Allia IGS 7 OR, Interventional fluoroscopic x-ray systems
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K232344.
Data sourced from openFDA. This site is unofficial and independent of the FDA.