VICTOREEN THEBES II, MODEL 7020— 510(k) K024284

Substantially Equivalent

Syncor Radiation Management

FDA 510(k) clearance K024284 for VICTOREEN THEBES II, MODEL 7020, Substantially Equivalent on 2003-03-11. Applicant: Syncor Radiation Management.

Clearance details

Applicant
Syncor Radiation Management
Product code
Code IYE
Advisory panel
Radiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Cleveland, OH, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code IYE

product code IYE
Malfunction
455
Other
3
Total
458

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.