RAD II SIMULATOR, RAD II KV IMAGER, DUAL RAD II KV IMAGER— 510(k) K101038

Name: FDA 510(k) clearance K101038
Creator: U.S. Food and Drug Administration
Published: 2010-08-17

Substantially Equivalent

Acceletronics Digital Imaging, LLC

FDA 510(k) clearance K101038 for RAD II SIMULATOR, RAD II KV IMAGER, DUAL RAD II KV IMAGER, Substantially Equivalent on 2010-08-17. Applicant: Acceletronics Digital Imaging, LLC. Device class: 2.

Clearance details

Applicant: Acceletronics Digital Imaging, LLC
Product code: Code KPQ
Device class: Class 2
Regulation: 21 CFR 892.5840
Advisory panel: Radiology
Date received: 2010-04-14
Decision date: 2010-08-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Exton, PA, US

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