3DXR— 510(k) K243446
Substantially EquivalentGE Medical Systems SCS
FDA 510(k) clearance K243446 for 3DXR, Substantially Equivalent on 2025-02-25. 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
- Traditional
- 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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.