ANYSCAN-S SPECT IMAGING SYSTEM— 510(k) K131625

Name: FDA 510(k) clearance K131625
Creator: U.S. Food and Drug Administration
Published: 2013-10-03

Substantially Equivalent

Absolute Imaging Solutions

FDA 510(k) clearance K131625 for ANYSCAN-S SPECT IMAGING SYSTEM, Substantially Equivalent on 2013-10-03. Applicant: Absolute Imaging Solutions. Device class: 2.

Clearance details

Applicant: Absolute Imaging Solutions
Product code: Code KPS
Device class: Class 2
Regulation: 21 CFR 892.1200
Advisory panel: Radiology
Date received: 2013-06-04
Decision date: 2013-10-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Stokesdale, NC, US

Download summary PDF View on FDA.gov ↗

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