Cleared Traditional

ACCENT

K050693 · Air Techniques, Inc. · Radiology
May 2005
Decision
70d
Days
Class 2
Risk

About This 510(k) Submission

K050693 is an FDA 510(k) clearance for the ACCENT, a System, X-ray, Extraoral Source, Digital (Class II — Special Controls, product code MUH), submitted by Air Techniques, Inc. (Hicksville, US). The FDA issued a Cleared decision on May 26, 2005, 70 days after receiving the submission on March 17, 2005. This device falls under the Radiology review panel. Regulated under 21 CFR 872.1800.

Submission Details

510(k) Number K050693 FDA.gov
FDA Decision Cleared SESE
Date Received March 17, 2005
Decision Date May 26, 2005
Days to Decision 70 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement

Device Classification

Product Code MUH — System, X-ray, Extraoral Source, Digital
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.1800

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