Cleared Traditional

K932357 - FUJI EC ID CAMERA
(FDA 510(k) Clearance)

K932357 · Fujifilm Medical System U.S.A., Inc. · Radiology

Jul 1993

Decision

73d

Days

Class 1

Risk

K932357 is an FDA 510(k) clearance for the FUJI EC ID CAMERA. This device is classified as a System, X-ray, Film Marking, Radiographic (Class I — General Controls, product code JAC).

Submitted by Fujifilm Medical System U.S.A., Inc. (Stamford, US). The FDA issued a Cleared decision on July 26, 1993, 73 days after receiving the submission on May 14, 1993.

This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1640.

Submission Details

510(k) Number	K932357 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 14, 1993
Decision Date	July 26, 1993
Days to Decision	73 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF