Cleared Traditional

RAD II SIMULATOR, RAD II KV IMAGER, DUAL RAD II KV IMAGER

K101038 · Acceletronics Digital Imaging, LLC · Radiology

Aug 2010

Decision

125d

Days

Class 2

Risk

About This 510(k) Submission

K101038 is an FDA 510(k) clearance for the RAD II SIMULATOR, RAD II KV IMAGER, DUAL RAD II KV IMAGER, a System, Simulation, Radiation Therapy (Class II — Special Controls, product code KPQ), submitted by Acceletronics Digital Imaging, LLC (Exton, US). The FDA issued a Cleared decision on August 17, 2010, 125 days after receiving the submission on April 14, 2010. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5840.

Submission Details

510(k) Number	K101038 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 14, 2010
Decision Date	August 17, 2010
Days to Decision	125 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF