PGK STEREOTACTIC DEVICE— 510(k) K911974
Substantially EquivalentNorthern Virginia Radiology and Nuclear Medicine
FDA 510(k) clearance K911974 for PGK STEREOTACTIC DEVICE, Substantially Equivalent on 1991-11-05. Applicant: Northern Virginia Radiology and Nuclear Medicine.
Clearance details
- Applicant
- Northern Virginia Radiology and Nuclear Medicine
- Product code
- Code HRX
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Falls Church, VA, US
Adverse events under product code HRX
product code HRX- Injury
- 623
- Malfunction
- 11,257
- Total
- 11,880
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.