HDR PROSTATE TEMPLATE AND ACCESSORIES— 510(k) K091230

Name: FDA 510(k) clearance K091230
Creator: U.S. Food and Drug Administration
Published: 2009-08-12

Substantially Equivalent

Photon Technologies Corporation

FDA 510(k) clearance K091230 for HDR PROSTATE TEMPLATE AND ACCESSORIES, Substantially Equivalent on 2009-08-12. Applicant: Photon Technologies Corporation. Device class: 2.

Clearance details

Applicant: Photon Technologies Corporation
Product code: Code JAQ
Device class: Class 2
Regulation: 21 CFR 892.5700
Advisory panel: Radiology
Date received: 2009-04-27
Decision date: 2009-08-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fayetteville, GA, US

Download summary PDF View on FDA.gov ↗

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