Innova IGS 5, Innova IGS 6, Discovery IGS 7, Discovery IGS 7 OR— 510(k) K181403
Substantially EquivalentGE Healthcare
FDA 510(k) clearance K181403 for Innova IGS 5, Innova IGS 6, Discovery IGS 7, Discovery IGS 7 OR, Substantially Equivalent on 2018-11-02. Applicant: GE Healthcare. Device class: 2.
Clearance details
- Applicant
- GE Healthcare
- 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
- Traditional
- Location
- Buc, FR
Recent devices under product code OWB
view allMore clearances from GE Healthcare
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 K181403
K-number listed on FDA's recall record- Z-1777-2024 — GE Healthcare Innova IGS 5, computed tomography x-ray system
- Z-1778-2024 — GE Healthcare Innova IGS 6, Interventional fluoroscopic x-ray systems
- Z-1782-2024 — GE Healthcare Allia IGS 5 Pulse, Interventional fluoroscopic x-ray systems
- Z-1783-2024 — GE Healthcare Allia IGS 5 Pulse, Interventional fluoroscopic x-ray systems
- Z-1864-2021 — GE Healthcare Innova IGS 3 (GTIN 00840682147378), Innova IGS 5 (GTIN 00840682124621), Innova IGS 6 (GTIN 00840682124614), Discovery IGS 7 (GTIN 00840682124638), and Discovery IGS 7 OR (GTIN00840682125888) interventional fluoroscopic x-ray systems.
- Z-1201-2019 — Innova IGS 6, Interventional Fluoroscopic X-Ray System used in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular and non-vascular, diagnostic and interventional procedures.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K181403.
Data sourced from openFDA. This site is unofficial and independent of the FDA.