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FDA 510(k)

HDR PROSTATE TEMPLATE AND ACCESSORIES

K-Number: K091230 · 2009-08-12

ApplicantPhoton Technologies Corporation
Decision Date2009-08-12
Product CodeJAQ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

HDR PROSTATE TEMPLATE AND ACCESSORIES is the device name listed in this FDA 510(k) record. The listed applicant is Photon Technologies Corporation. It received FDA 510(k) clearance on 2009-08-12 under 510(k) number K091230. The device is classified under product code JAQ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HDR PROSTATE TEMPLATE AND ACCESSORIES?

HDR PROSTATE TEMPLATE AND ACCESSORIES is a medical device that received FDA 510(k) clearance on 2009-08-12. The listed applicant is Photon Technologies Corporation. The 510(k) number is K091230.

When did HDR PROSTATE TEMPLATE AND ACCESSORIES receive FDA 510(k) clearance?

HDR PROSTATE TEMPLATE AND ACCESSORIES received FDA 510(k) clearance on 2009-08-12, under 510(k) number K091230.

Who is the listed applicant for HDR PROSTATE TEMPLATE AND ACCESSORIES?

The FDA 510(k) record lists Photon Technologies Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HDR PROSTATE TEMPLATE AND ACCESSORIES?

The FDA product code for HDR PROSTATE TEMPLATE AND ACCESSORIES is JAQ.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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