Cleared Traditional

K926404 - KODAK X-OMATIC IDENTIFICATION CAMERA, MODEL 4 & 4L
(FDA 510(k) Clearance)

K926404 · Eastman Kodak Company · Radiology device

Mar 1993

Decision

73d

Days

Class 1

Risk

K926404 is an FDA 510(k) clearance for the KODAK X-OMATIC IDENTIFICATION CAMERA, MODEL 4 & 4L. This device is classified as a System, X-ray, Film Marking, Radiographic (Class I - General Controls, product code JAC).

Submitted by Eastman Kodak Company (Rochester, US). The FDA issued a Cleared decision on March 4, 1993, 73 days after receiving the submission on December 21, 1992.

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

Submission Details

510(k) Number	K926404 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	December 21, 1992
Decision Date	March 04, 1993
Days to Decision	73 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF