PRECISION 500D R&F X-RAY SYSTEM— 510(k) K081091
Substantially EquivalentGE Healthcare
FDA 510(k) clearance K081091 for PRECISION 500D R&F X-RAY SYSTEM, Substantially Equivalent on 2008-06-11. Applicant: GE Healthcare.
Clearance details
- Applicant
- GE Healthcare
- Product code
- Code JAA
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Waukesha, WI, US
Adverse events under product code JAA
product code JAA- Other
- 1
- Total
- 1
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.