FDA product code JAQ: System, Applicator, Radionuclide, Remote-Controlled
JAQ is the FDA product code for system, applicator, radionuclide, remote-controlled. It is a Class II device, regulated under 21 CFR 892.5700 and reviewed by the Radiology panel. FDA has cleared 208 510(k) submissions under JAQ, 21 in the last five years, from 52 different applicants. The average 510(k) review took 136 days (median 99); 136 days on average over the last three years. FDA has posted 52 recalls for JAQ devices, 3 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | System, Applicator, Radionuclide, Remote-Controlled |
| Device class | Class II |
| Regulation | 21 CFR 892.5700 |
| Review panel | RA — Radiology |
| Medical specialty | Radiology |
| Premarket route | 510(k) |
510(k) clearances per year for JAQ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 7 | 260 |
| 2018 | 7 | 272 |
| 2019 | 2 | 79 |
| 2020 | 4 | 105 |
| 2022 | 1 | 85 |
| 2023 | 2 | 202 |
| 2024 | 10 | 138 |
| 2025 | 6 | 132 |
| 2026 | 2 | 138 |
Compare with all 510(k) review times · Search every JAQ clearance
Top JAQ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Varian Medical Systems, Inc. | 50 | 2025-05-09 |
| Mick Radio-Nuclear Instruments, Inc. | 22 | 2023-08-30 |
| Nucletron Corp. | 14 | 2009-10-08 |
| Nucletron Corporation | 10 | 2009-05-18 |
| Nucletron B.V. | 9 | 2026-07-24 |
47 more applicants have JAQ clearances. See the full list in Caduvo.
Most recent JAQ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K262383 | Nucletron B.V. | LumenCare Azure | 2026-07-24 | 11 |
| K252717 | Varian Medical Systems | MAASTRO Rectal Applicator Set | 2026-05-20 | 265 |
| K251037 | Nucletron B.V. | Rectal Applicator | 2025-12-19 | 260 |
| K252884 | Varian Medical Systems | Guided Aarhus Applicator Set | 2025-11-19 | 70 |
| K250299 | Varian Medical Systems, Inc. | CT/ MR Tandem and Ovoid Set | 2025-05-09 | 98 |
Recalls for JAQ devices
52 product recalls in 27 recall events; 3 initiated in the last five years and 3 still open. Most recent: 2026-04-03.
| Year | Recalls |
|---|---|
| 2019 | 1 |
| 2026 | 3 |
Frequently asked questions
What is FDA product code JAQ?
JAQ is the FDA product code for system, applicator, radionuclide, remote-controlled. It is a Class II device, regulated under 21 CFR 892.5700 and reviewed by the Radiology panel.
What device class is JAQ?
Class II, regulation 21 CFR 892.5700. Typical premarket route: 510(k).
How long does a 510(k) take for product code JAQ?
Across 208 cleared submissions the average was 136 days from receipt to decision (median 99).
Which companies have the most JAQ clearances?
Varian Medical Systems, Inc. (50); Mick Radio-Nuclear Instruments, Inc. (22); Nucletron Corp. (14); Nucletron Corporation (10); Nucletron B.V. (9).
Have JAQ devices been recalled?
Yes: 52 product recalls across 27 recall events; the most recent began 2026-04-03.
Next steps
- Run an FDA pathway report with predicate devices for product code JAQ
- Run a recall and safety report across every JAQ manufacturer
- Watch product code JAQ for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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