K800998Substantially Equivalent

Atlas-S X-Ray System W/ketromat Gen.

Name: K800998 Atlas-S X-Ray System W/ketromat Gen.
Creator: General X-Ray, Inc.
Published: 1980-05-28
License: https://open.fda.gov/license/

General X-Ray, Inc., Mchenry IL / Traditional, Substantially Equivalent

FDA source

K800998 is the FDA 510(k) clearance record for ATLAS-S X-RAY SYSTEM W/KETROMAT GEN., cleared for General X-Ray, Inc. on 1980-05-28. FDA records list 14 510(k) clearances for General X-Ray, Inc., from 1978-06-27 to 1980-05-28. As of 2026-09-10, FDA records show no recalls naming K800998.

Clearance record

Decision date: 1980-05-28
Received: 1980-04-25 (33 days to decision)
Review panel: Unknown
Applicant: General X-Ray, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review: No