MODIFICATION TO D-SPECT CARDIAC SCANNER SYSTEM— 510(k) K072468

Name: FDA 510(k) clearance K072468
Creator: U.S. Food and Drug Administration
Published: 2007-10-01

Substantially Equivalent

Spectrum Dynamics , Ltd.

FDA 510(k) clearance K072468 for MODIFICATION TO D-SPECT CARDIAC SCANNER SYSTEM, Substantially Equivalent on 2007-10-01. Applicant: Spectrum Dynamics , Ltd.. Device class: 2.

Clearance details

Applicant: Spectrum Dynamics , Ltd.
Product code: Code KPS
Device class: Class 2
Regulation: 21 CFR 892.1200
Advisory panel: Radiology
Date received: 2007-09-04
Decision date: 2007-10-01
Decision: Substantially Equivalent
Clearance type: Special
Location: Kfar Saba, IL

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.