FDA product code · Radiology · Class 2
JAQ: System, Applicator, Radionuclide, Remote-Controlled
JAQ is FDA's product code for "System, Applicator, Radionuclide, Remote-Controlled": a Class 2 device classified under 21 CFR 892.5700, reviewed by the Radiology panel.
510(k) review time for JAQ
Across 34 510(k) clearances under JAQ decided from 2018-01-01 to 2026-10-06, the median was 126 days from FDA receipt to decision. Half took between 75 and 230 days, and 80% were decided within 245 days. These are past clearances, not a forecast for a new submission.
| Fastest | 11 |
|---|---|
| 25th percentile | 75 |
| Median | 126 |
| 75th percentile | 230 |
| 80th percentile | 245 |
| 90th percentile | 264 |
| Slowest | 583 |
| Year | Median days | n |
|---|---|---|
| 2018 | 252 | 7 |
| 2024 | 126 | 10 |
| 2025 | 91 | 6 |
Source: openFDA 510(k) records, snapshot of 2026-10-06 (openFDA data as of 2026-09-28). Compare 510(k) review times across all device types, see every code side by side in the Clearance Timeline Estimator, or browse the clearances themselves in PredicateScope.
JAQ in the public FDA record
| 510(k) clearances, all years | 208 |
|---|---|
| Device recalls | 52 |
| Establishment listings | 187 |
| GUDID device identifiers | 4,244 |
Counts of records, not of devices or events. Adverse event reports for JAQ are in MAUDEScope, as counts with the query shown: MAUDE has no denominator, so a report count is not a rate and does not show that a device caused an event.
FDA-recognized standards that cite JAQ
3 FDA recognized consensus standards cite JAQ, among them IEC 61674 Edition 2.0 2012-11; IEC 60601-2-17 Edition 3.0 2013-11; IEC 61674 Edition 3.0 2024-07. Horizontal standards such as biocompatibility, sterilization and software standards can apply without citing the code.
- 12-259 IEC 61674 Edition 2.0 2012-11 — Medical electrical equipment -- Dosimeters with ionization chambers and/or semiconductor detectors as used in X-ray diagnostic imaging
- 12-272 IEC 60601-2-17 Edition 3.0 2013-11 — Medical electrical equipment - Part 2-17: Particular requirements for the safety of automatically-controlled brachytherapy afterloading equipment
- 12-362 IEC 61674 Edition 3.0 2024-07 — Medical electrical equipment -- Dosimeters with ionization chambers and/or semiconductor detectors as used in X-ray diagnostic imaging
Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.