510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K091230Substantially Equivalent

Hdr Prostate Template and Accessories

Photon Technologies Corporation, Fayetteville GA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K091230 is the FDA 510(k) clearance record for HDR PROSTATE TEMPLATE AND ACCESSORIES, a class II device, cleared for Photon Technologies Corporation on under FDA product code JAQ (System, Applicator, Radionuclide, Remote-Controlled). FDA records list one 510(k) clearance for Photon Technologies Corporation. As of , FDA records show no recalls naming K091230.

Clearance record

Decision date
Received
(107 days to decision)
Product code
JAQ System, Applicator, Radionuclide, Remote-Controlled
Regulation
21 CFR 892.5700
Device class
Class II
Review panel
Radiology
Applicant
Photon Technologies Corporation 1572 N. Hwy. 85, Suite 308, Fayetteville GA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code JAQ

Trailing 12 months
4 clearances under product code JAQ in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code JAQ, trailing twelve months
MonthClearances
November 20251
December 20251
January 20260
February 20260
March 20260
April 20260
May 20261
June 20260
July 20261
August 20260
September 20260
October 20260