EXPLORER 4D TREATMENT PLANNING SYSTEM— 510(k) K093588

Name: FDA 510(k) clearance K093588
Creator: U.S. Food and Drug Administration
Published: 2010-01-11

Substantially Equivalent

American Radiosurgery, Inc.

FDA 510(k) clearance K093588 for EXPLORER 4D TREATMENT PLANNING SYSTEM, Substantially Equivalent on 2010-01-11. Applicant: American Radiosurgery, Inc.. Device class: 2.

Clearance details

Applicant: American Radiosurgery, Inc.
Product code: Code MUJ
Device class: Class 2
Regulation: 21 CFR 892.5050
Advisory panel: Radiology
Date received: 2009-11-19
Decision date: 2010-01-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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