Cleared Traditional

AP-6CR CINERADIOGRAPHIC FILM PROCESSOR

K915365 · The Allen Products Co. · Radiology

Aug 1992

Decision

274d

Days

Class 2

Risk

About This 510(k) Submission

K915365 is an FDA 510(k) clearance for the AP-6CR CINERADIOGRAPHIC FILM PROCESSOR, a Processor, Cine Film (Class II — Special Controls, product code IXX), submitted by The Allen Products Co. (Milford, US). The FDA issued a Cleared decision on August 27, 1992, 274 days after receiving the submission on November 27, 1991. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1900.

Submission Details

510(k) Number	K915365 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 27, 1991
Decision Date	August 27, 1992
Days to Decision	274 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Statement