MINI-GAMMA CAMERA, MODELS MGC500-101U AND MGC500-301U— 510(k) K043293

Name: FDA 510(k) clearance K043293
Creator: U.S. Food and Drug Administration
Published: 2004-12-17

Substantially Equivalent

Acrorad Co., Ltd.

FDA 510(k) clearance K043293 for MINI-GAMMA CAMERA, MODELS MGC500-101U AND MGC500-301U, Substantially Equivalent on 2004-12-17. Applicant: Acrorad Co., Ltd.. Device class: 2.

Clearance details

Applicant: Acrorad Co., Ltd.
Product code: Code KPS
Device class: Class 2
Regulation: 21 CFR 892.1200
Advisory panel: Radiology
Date received: 2004-11-29
Decision date: 2004-12-17
Decision: Substantially Equivalent
Clearance type: Special
Location: Brookeville, MD, US

Download summary PDF View on FDA.gov ↗

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