FDA product code · Radiology · Class 2
JAK: System, X-Ray, Tomography, Computed
JAK is FDA's product code for "System, X-Ray, Tomography, Computed": a Class 2 device classified under 21 CFR 892.1750, reviewed by the Radiology panel.
510(k) review time for JAK
Across 231 510(k) clearances under JAK decided from 2018-01-01 to 2026-10-06, the median was 132 days from FDA receipt to decision. Half took between 78 and 199 days, and 80% were decided within 227 days. These are past clearances, not a forecast for a new submission.
| Fastest | 17 |
|---|---|
| 25th percentile | 78 |
| Median | 132 |
| 75th percentile | 199 |
| 80th percentile | 227 |
| 90th percentile | 260 |
| Slowest | 614 |
| Year | Median days | n |
|---|---|---|
| 2018 | 114 | 24 |
| 2019 | 94 | 28 |
| 2020 | 112 | 30 |
| 2021 | 145 | 20 |
| 2022 | 131 | 30 |
| 2023 | 139 | 27 |
| 2024 | 141 | 26 |
| 2025 | 141 | 27 |
| 2026 (to 10-06, partial) | 156 | 19 |
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.
JAK in the public FDA record
| 510(k) clearances, all years | 823 |
|---|---|
| Device recalls | 865 |
| Establishment listings | 1,236 |
| GUDID device identifiers | 1,296 |
Counts of records, not of devices or events. Adverse event reports for JAK 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 JAK
8 FDA recognized consensus standards cite JAK, 1 of them recognized only in part, among them IEC 61223-2-6 Second Edition 2006-11; IEEE Std 3333.2.1-2015; IEC 60601-2-44 Edition 3.2: 2016. Horizontal standards such as biocompatibility, sterilization and software standards can apply without citing the code.
- 12-226 IEC 61223-2-6 Second Edition 2006-11 — Evaluation and routine testing in medical imaging departments - Part 2-6: Constancy tests - Imaging performance of computed tomography X-ray equipment
- 12-292 IEEE Std 3333.2.1-2015 — IEEE Recommended Practice for Three-Dimensional (3D) Medical Modeling
- 12-302 IEC 60601-2-44 Edition 3.2: 2016 (partial recognition) — Medical electrical equipment - Part 2-44: Particular requirements for the basic safety and essential performance of x-ray equipment for computed tomography
- 12-325 NEMA Standards Publication XR 25 -2019 — Computed Tomography Dose Check
- 12-328 IEC 61223-3-5 Edition 2.0 2019-09 — Evaluation and routine testing in medical imaging departments - Part 3-5: Acceptance tests - Imaging performance of computed tomography X-ray equipment [Including: Technical Corrigendum 1 (2022)]
- 12-330 NEMA Standards Publication XR 28-2018 (R2023) — Supplemental Requirements for User Information and System Function Related to Dose in CT
- 12-363 NEMA PS 3.1 - 3.20 2024e — Digital Imaging and Communications in Medicine (DICOM) Set
- 12-385 NEMA PS 3.1 - 3.20 2025d — Digital Imaging and Communications in Medicine (DICOM) Set
Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.