D-SPECT Processing and Reviewing Workstation— 510(k) K160120

Name: FDA 510(k) clearance K160120
Creator: U.S. Food and Drug Administration
Published: 2016-03-21

Substantially Equivalent

Spectrum Dynamics , Ltd.

FDA 510(k) clearance K160120 for D-SPECT Processing and Reviewing Workstation, Substantially Equivalent on 2016-03-21. 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: 2016-01-19
Decision date: 2016-03-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Caesarea, 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.