FDA product code JAK: System, X-Ray, Tomography, Computed
JAK is the FDA product code for system, x-ray, tomography, computed. It is a Class II device, regulated under 21 CFR 892.1750 and reviewed by the Radiology panel. FDA has cleared 824 510(k) submissions under JAK, 128 in the last five years, from 203 different applicants. The average 510(k) review took 108 days (median 86); 157 days on average over the last three years. FDA has posted 871 recalls for JAK devices, 148 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | System, X-Ray, Tomography, Computed |
| Device class | Class II |
| Regulation | 21 CFR 892.1750 |
| Review panel | RA — Radiology |
| Medical specialty | Radiology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for JAK
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 29 | 111 |
| 2018 | 24 | 141 |
| 2019 | 28 | 111 |
| 2020 | 30 | 112 |
| 2021 | 20 | 160 |
| 2022 | 30 | 155 |
| 2023 | 27 | 153 |
| 2024 | 26 | 153 |
| 2025 | 27 | 158 |
| 2026 | 18 | 159 |
Compare with all 510(k) review times · Search every JAK clearance
Top JAK applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Siemens Medical Solutions USA, Inc. | 105 | 2026-03-20 |
| Toshiba America Medical Systems, In.C | 35 | 2012-09-21 |
| General Electric Co. | 31 | 2011-09-09 |
| Ge Medical Systems, LLC | 30 | 2026-06-24 |
| Toshibamedical Systems Corporation | 27 | 2018-02-23 |
198 more applicants have JAK clearances. See the full list in Caduvo.
Most recent JAK clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K261229 | Fujifilm Corporation | SCENARIA View Phase 6.0 | 2026-09-18 | 156 |
| K253836 | Fujifilm Corporation | FCT iStream Phase 2 | 2026-09-04 | 277 |
| K253450 | NeuroLogica Corp., a Samsung Company | BodyTom Elite (NL4000) | 2026-07-28 | 299 |
| K253770 | GE Medical Systems SCS | CardIQ Suite | 2026-07-21 | 237 |
| K253560 | Ge Medical Systems, LLC | Enhanced Boundary for PCCT | 2026-06-24 | 219 |
Recalls for JAK devices
871 product recalls in 373 recall events; 148 initiated in the last five years and 183 still open. Most recent: 2026-08-11.
| Year | Recalls |
|---|---|
| 2017 | 50 |
| 2018 | 78 |
| 2019 | 63 |
| 2020 | 24 |
| 2021 | 42 |
| 2022 | 15 |
| 2023 | 37 |
| 2024 | 23 |
| 2025 | 42 |
| 2026 | 27 |
Frequently asked questions
What is FDA product code JAK?
JAK is the FDA product code for system, x-ray, tomography, computed. It is a Class II device, regulated under 21 CFR 892.1750 and reviewed by the Radiology panel.
What device class is JAK?
Class II, regulation 21 CFR 892.1750. Typical premarket route: 510(k).
How long does a 510(k) take for product code JAK?
Across 824 cleared submissions the average was 108 days from receipt to decision (median 86).
Which companies have the most JAK clearances?
Siemens Medical Solutions USA, Inc. (105); Toshiba America Medical Systems, In.C (35); General Electric Co. (31); Ge Medical Systems, LLC (30); Toshibamedical Systems Corporation (27).
Have JAK devices been recalled?
Yes: 871 product recalls across 373 recall events; the most recent began 2026-08-11.
Next steps
- Run an FDA pathway report with predicate devices for product code JAK
- Run a recall and safety report across every JAK manufacturer
- Watch product code JAK 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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