ROTATING GAMMA SYSTEM. GAMMA ART-6000— 510(k) K060314

Name: FDA 510(k) clearance K060314
Creator: U.S. Food and Drug Administration
Published: 2006-04-06

Substantially Equivalent

American Radiosurgery, Inc.

FDA 510(k) clearance K060314 for ROTATING GAMMA SYSTEM. GAMMA ART-6000, Substantially Equivalent on 2006-04-06. Applicant: American Radiosurgery, Inc.. Device class: 2.

Clearance details

Applicant: American Radiosurgery, Inc.
Product code: Code IWB
Device class: Class 2
Regulation: 21 CFR 892.5750
Advisory panel: Radiology
Date received: 2006-02-08
Decision date: 2006-04-06
Decision: Substantially Equivalent
Clearance type: Special
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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