Cleared Traditional

JAMIESON MODEL 2100 CINE FILM PROCESSOR AND KODAK CINEFLURE PROCESSOR MODEL 2100

K963334 · Jamieson Film Co. · Radiology

Sep 1996

Decision

16d

Days

Class 2

Risk

About This 510(k) Submission

K963334 is an FDA 510(k) clearance for the JAMIESON MODEL 2100 CINE FILM PROCESSOR AND KODAK CINEFLURE PROCESSOR MODEL 2100, 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 11, 1996, 16 days after receiving the submission on August 26, 1996. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1900.

Submission Details

510(k) Number	K963334 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 26, 1996
Decision Date	September 11, 1996
Days to Decision	16 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF