PRISM 3000XPV SYSTEM (210714)— 510(k) K961577

Name: FDA 510(k) clearance K961577
Creator: U.S. Food and Drug Administration
Published: 1996-07-23

Substantially Equivalent

Philips Medical Systems (Cleveland), Inc.

FDA 510(k) clearance K961577 for PRISM 3000XPV SYSTEM (210714), Substantially Equivalent on 1996-07-23. Applicant: Philips Medical Systems (Cleveland), Inc.. Device class: 2.

Clearance details

Applicant: Philips Medical Systems (Cleveland), Inc.
Product code: Code KPS
Device class: Class 2
Regulation: 21 CFR 892.1200
Advisory panel: Radiology
Date received: 1996-04-24
Decision date: 1996-07-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cleveland, OH, US

Download summary PDF View on FDA.gov ↗

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