Positron Emission Tomography (PET) and Computed Tomography (CT) System, Positron Emission Tomography (PET) and Computed Tomography (CT) System— 510(k) K151403

Name: FDA 510(k) clearance K151403
Creator: U.S. Food and Drug Administration
Published: 2015-11-02

Substantially Equivalent

Neusoft Medical Systems Co., Ltd.

FDA 510(k) clearance K151403 for Positron Emission Tomography (PET) and Computed Tomography (CT) System, Positron Emission Tomography (PET) and Computed Tomography (CT) System, Substantially Equivalent on 2015-11-02. Applicant: Neusoft Medical Systems Co., Ltd.. Device class: 2.

Clearance details

Applicant: Neusoft Medical Systems Co., Ltd.
Product code: Code KPS
Device class: Class 2
Regulation: 21 CFR 892.1200
Advisory panel: Radiology
Date received: 2015-05-26
Decision date: 2015-11-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shenyang, CN

Download summary PDF View on FDA.gov ↗

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