NEUROSPECTQUAD GAMMA CAMERA— 510(k) K013353

Name: FDA 510(k) clearance K013353
Creator: U.S. Food and Drug Administration
Published: 2002-03-04

Substantially Equivalent

Nuclear Cardiology Systems, Inc.

FDA 510(k) clearance K013353 for NEUROSPECTQUAD GAMMA CAMERA, Substantially Equivalent on 2002-03-04. Applicant: Nuclear Cardiology Systems, Inc.. Device class: 2.

Clearance details

Applicant: Nuclear Cardiology Systems, Inc.
Product code: Code KPS
Device class: Class 2
Regulation: 21 CFR 892.1200
Advisory panel: Radiology
Date received: 2001-10-09
Decision date: 2002-03-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Boulder, CO, US

Download summary PDF View on FDA.gov ↗

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