510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K120344Substantially Equivalent

Radiapak Brachytherapy Applicator Balloon Device

Radiadyne, LLC (Specification Developer), Houston TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K120344 is the FDA 510(k) clearance record for RADIAPAK BRACHYTHERAPY APPLICATOR BALLOON DEVICE, a class II device, cleared for Radiadyne, LLC (Specification Developer) on under FDA product code JAQ (System, Applicator, Radionuclide, Remote-Controlled). FDA records list one 510(k) clearance for Radiadyne, LLC (Specification Developer). As of , FDA records show no recalls naming K120344.

Clearance record

Decision date
Received
(90 days to decision)
Product code
JAQ System, Applicator, Radionuclide, Remote-Controlled
Regulation
21 CFR 892.5700
Device class
Class II
Review panel
Radiology
Applicant
Radiadyne, LLC (Specification Developer) 11931 Wickchester Ln., Houston TX
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