IMIX PANORAD AND SOMARAD— 510(k) K101435

Substantially Equivalent

Imix Adr Finland OY

FDA 510(k) clearance K101435 for IMIX PANORAD AND SOMARAD, Substantially Equivalent on 2010-09-15. Applicant: Imix Adr Finland OY.

Clearance details

Applicant: Imix Adr Finland OY
Product code: Code KPR
Advisory panel: Radiology
Date received: 2010-05-21
Decision date: 2010-09-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Naples, FL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KPR

product code KPR

Other: 6
Total: 6

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.