Cleared Traditional

K882519 - X-RAY MARKER
(FDA 510(k) Clearance)

K882519 · Karlin Technology, Inc. · Radiology device

Aug 1988

Decision

53d

Days

Class 1

Risk

K882519 is an FDA 510(k) clearance for the X-RAY MARKER. This device is classified as a System, X-ray, Film Marking, Radiographic (Class I - General Controls, product code JAC).

Submitted by Karlin Technology, Inc. (Marina Del Rey, US). The FDA issued a Cleared decision on August 9, 1988, 53 days after receiving the submission on June 17, 1988.

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

Submission Details

510(k) Number	K882519 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	June 17, 1988
Decision Date	August 09, 1988
Days to Decision	53 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	—