STASYS MOTION CORRECTION SOFTWARE— 510(k) K082904

Name: FDA 510(k) clearance K082904
Creator: U.S. Food and Drug Administration
Published: 2008-12-17

Substantially Equivalent

Digirad Corp.

FDA 510(k) clearance K082904 for STASYS MOTION CORRECTION SOFTWARE, Substantially Equivalent on 2008-12-17. Applicant: Digirad Corp.. Device class: 2.

Clearance details

Applicant: Digirad Corp.
Product code: Code KPS
Device class: Class 2
Regulation: 21 CFR 892.1200
Advisory panel: Radiology
Date received: 2008-09-30
Decision date: 2008-12-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Poway, CA, US

Download summary PDF View on FDA.gov ↗

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