IMIX PANORAD AND SOMARAD— 510(k) K101435

Name: FDA 510(k) clearance K101435
Creator: U.S. Food and Drug Administration
Published: 2010-09-15

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. Device class: 2.

Clearance details

Applicant: Imix Adr Finland OY
Product code: Code KPR
Device class: Class 2
Regulation: 21 CFR 892.1680
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 ↗

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K113855 — PANORAD, PANORAD SL2012-01-25
K073114 — IMIX INSIGHT X-RAY SYSTEMS2008-01-17
K072867 — IMIX 2000 DIGITAL RADIOGRAPHY SYSTEM, MODELS UNV 3K, UNV 3KW, UNV 4K2007-11-21

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.