STANDARD IMAGING IMSURE BRACHY QA SOFTWARE, MODEL 91331— 510(k) K082773

Substantially Equivalent

Standard Imaging, Inc.

FDA 510(k) clearance K082773 for STANDARD IMAGING IMSURE BRACHY QA SOFTWARE, MODEL 91331, Substantially Equivalent on 2008-11-19. Applicant: Standard Imaging, Inc..

Clearance details

Applicant: Standard Imaging, Inc.
Product code: Code IYE
Advisory panel: Radiology
Date received: 2008-09-22
Decision date: 2008-11-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Middleton, WI, US

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Adverse events under product code IYE

product code IYE

Malfunction: 455
Other: 3
Total: 458

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.