HYPER SOURCE-UNIT ROTATING GAMMA SYSTEM— 510(k) K131777

Name: FDA 510(k) clearance K131777
Creator: U.S. Food and Drug Administration
Published: 2014-02-28

Substantially Equivalent

Hyper Technology, Inc.

FDA 510(k) clearance K131777 for HYPER SOURCE-UNIT ROTATING GAMMA SYSTEM, Substantially Equivalent on 2014-02-28. Applicant: Hyper Technology, Inc.. Device class: 2.

Clearance details

Applicant: Hyper Technology, Inc.
Product code: Code IWB
Device class: Class 2
Regulation: 21 CFR 892.5750
Advisory panel: Radiology
Date received: 2013-06-17
Decision date: 2014-02-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shanghai, CN

Download summary PDF View on FDA.gov ↗

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