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System, Applicator, Radionuclide, Remote-Controlled

FDA product code JAQ · Class 2 · Radiology

4,228
Registered devices
413
Adverse events
52
Recalls
208
510(k) clearances

Devices with this code

H.A.M. Sizing Template, 05cm — MICK RADIO NUCLEAR INSTRUMENT, INCMartinez Prostate Template — Nucletron B.V.MicroSelectron Digital — Nucletron B.V.Channel marker clips, coded 13-24 — Varian Medical Systems Deutschland GmbHTitanium central clamping mechanism — Varian Medical Systems Deutschland GmbHH.A.M., 12-Channel, 130cm cath, Varian-Gammamed — MICK RADIO NUCLEAR INSTRUMENT, INCIntrauterine tandem, 30 degrees, 2 cm, CT/ MR — Varian Medical Systems Deutschland GmbHFlexitron — Nucletron B.V.NA — Nucletron B.V.X-ray Catheters — Nucletron B.V.Universal Applicator incl. plug, D=3mm, L=1400mm (non sterile) — Eckert & Ziegler BEBIG GmbHBest Medical International — BEST MEDICAL INTERNATIONAL, INC.Vaginal cylinder with lever, 30mm diameter x 50mm length — Varian Medical Systems Deutschland GmbHBreast CT/MR Template — Nucletron B.V.MicroSelectron Digital — Nucletron B.V.Breast Template Set — Nucletron B.V.NA — Nucletron B.V.Best Medical International — BEST MEDICAL INTERNATIONAL, INC.Flexible Implant Tubes — Nucletron B.V.Prostate Stepper Template — Nucletron B.V.Prostate Stepper Template — Nucletron B.V.H.A.M.,13-Chan w blank insert holes,Slot — MICK RADIO NUCLEAR INSTRUMENT, INCH.A.M.,11-Chan w blank insert holes,Slot — MICK RADIO NUCLEAR INSTRUMENT, INCTitanium needle 200mm, 16 gauge (1.65mm), blunt trocar point — Varian Medical Systems Deutschland GmbH

Recent recalls

DateFirmReason
2026-04-03Elekta, Inc.Due to safety concerns regarding the detachment of the tip of the intrauterine tube (IU tube) that may remain within a patient.
2026-04-03Elekta, Inc.Due to safety concerns regarding the detachment of the tip of the intrauterine tube (IU tube) that may remain within a patient.
2026-04-03Elekta, Inc.Due to safety concerns regarding the detachment of the tip of the intrauterine tube (IU tube) that may remain within a patient.
2019-11-18Nucletron BVA component failure may lead to treatment interruption or incorrect source positioning.
2015-05-18Varian Medical Systems IncAfter an application freeze and restart of the VariSource iX series by power cycling, the Partial Fraction generated by the system will not be correct. The appl
2015-05-18Varian Medical Systems IncVarian has discovered that there is a discrepancy in the absolute dose rate given with the Leipzig-style Surface Applicator's Instructions for Use (IFU): Dose C
2013-08-09Varian Medical Systems, Inc.The recall was initiated after Varian Medical became aware the Lexan templates of the Breast Bridge Template System could become bent and turn opaque after stea
2012-09-28Varian Medical Systems, Inc.The guide tube which is part of the Segmented Cervix Applicator Set is difficult to disconnect from cervical sleeve.
2012-04-12Varian Medical Systems, Inc.A medical device used in brachytherapy may become contaminated and can cause infections, toxicity or allergic reactions.
2012-04-12Varian Medical Systems, Inc.A medical device used in brachytherapy may become contaminated and can cause infections, toxicity or allergic reactions.

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.