Cleared Traditional

JAMIESON JT-CRP CINE FILM PROCESSOR

K913241 · Jamieson Film Co. · Radiology
Sep 1991
Decision
64d
Days
Class 2
Risk

About This 510(k) Submission

K913241 is an FDA 510(k) clearance for the JAMIESON JT-CRP CINE FILM PROCESSOR, a Processor, Cine Film (Class II — Special Controls, product code IXX), submitted by Jamieson Film Co. (Dallas, US). The FDA issued a Cleared decision on September 24, 1991, 64 days after receiving the submission on July 22, 1991. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1900.

Submission Details

510(k) Number K913241 FDA.gov
FDA Decision Cleared SESE
Date Received July 22, 1991
Decision Date September 24, 1991
Days to Decision 64 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement

Device Classification

Product Code IXX — Processor, Cine Film
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1900