PRISM 3000 NUCLEAR GAMMA CAMERA SYSTEM MODIFICATION— 510(k) K934722

Name: FDA 510(k) clearance K934722
Creator: U.S. Food and Drug Administration
Published: 1994-05-13

Substantially Equivalent

Ohio Imaging, Inc.

FDA 510(k) clearance K934722 for PRISM 3000 NUCLEAR GAMMA CAMERA SYSTEM MODIFICATION, Substantially Equivalent on 1994-05-13. Applicant: Ohio Imaging, Inc.. Device class: 2.

Clearance details

Applicant: Ohio Imaging, Inc.
Product code: Code KPS
Device class: Class 2
Regulation: 21 CFR 892.1200
Advisory panel: Radiology
Date received: 1993-09-29
Decision date: 1994-05-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cleveland, OH, US

Download summary PDF View on FDA.gov ↗

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