Cleared Traditional

K924345 - RADIOGRAPHIC FILM MARKETING SYSTEM
(FDA 510(k) Clearance)

K924345 · Fischer Imaging Corp. · Radiology

Nov 1992

Decision

92d

Days

Class 1

Risk

K924345 is an FDA 510(k) clearance for the RADIOGRAPHIC FILM MARKETING SYSTEM, a System, X-ray, Film Marking, Radiographic (Class I — General Controls, product code JAC), submitted by Fischer Imaging Corp. (Denver, US). The FDA issued a Cleared decision on November 27, 1992, 92 days after receiving the submission on August 27, 1992. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1640.

Submission Details

510(k) Number	K924345 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 27, 1992
Decision Date	November 27, 1992
Days to Decision	92 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Statement