QUANTITATIVE GATED SPECT (QGS), QUANTITATIVE PERFUSION SPECT (QPS)— 510(k) K011572

Name: FDA 510(k) clearance K011572
Creator: U.S. Food and Drug Administration
Published: 2001-06-15

Substantially Equivalent

Digirad Corp.

FDA 510(k) clearance K011572 for QUANTITATIVE GATED SPECT (QGS), QUANTITATIVE PERFUSION SPECT (QPS), Substantially Equivalent on 2001-06-15. 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: 2001-05-21
Decision date: 2001-06-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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