FDA product code JAA: System, X-Ray, Fluoroscopic, Image-Intensified
JAA is the FDA product code for system, x-ray, fluoroscopic, image-intensified. It is a Class II device, regulated under 21 CFR 892.1650 and reviewed by the Radiology panel. FDA has cleared 300 510(k) submissions under JAA, 9 in the last five years, from 158 different applicants. The average 510(k) review took 89 days (median 67); 166 days on average over the last three years. FDA has posted 223 recalls for JAA devices, 33 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | System, X-Ray, Fluoroscopic, Image-Intensified |
| Device class | Class II |
| Regulation | 21 CFR 892.1650 |
| Review panel | RA — Radiology |
| Medical specialty | Radiology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for JAA
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 77 |
| 2018 | 3 | 88 |
| 2019 | 6 | 69 |
| 2020 | 4 | 90 |
| 2021 | 6 | 92 |
| 2022 | 1 | 24 |
| 2023 | 2 | 26 |
| 2024 | 3 | 128 |
| 2025 | 2 | 124 |
| 2026 | 1 | 247 |
Compare with all 510(k) review times · Search every JAA clearance
Top JAA applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Toshiba America Medical Systems, In.C | 13 | 2014-06-13 |
| Siemens Medical Solutions USA, Inc. | 10 | 2011-06-03 |
| Fischer Imaging Corp. | 10 | 1998-07-16 |
| Shimadzu Medical Systems | 10 | 1996-12-18 |
| General Electric Co. | 10 | 1994-09-23 |
153 more applicants have JAA clearances. See the full list in Caduvo.
Most recent JAA clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K253103 | Varex Imaging Corporation | Nexus DRF Digital X-ray Imaging System | 2026-05-29 | 247 |
| K251650 | Imaging Engineering, LLC | Insight Enhanced DRF (EN-1002-01) | 2025-09-16 | 110 |
| K242488 | Omega Medical Imaging, LLC | Soteria E-View | 2025-01-06 | 138 |
| K242948 | Nrt X-Ray A/S | Adora DRFi (04550010) | 2024-12-23 | 89 |
| K233380 | Dornier Medtech America | TRIDENT Mobile Fluoroscopy System | 2024-06-26 | 268 |
Recalls for JAA devices
223 product recalls in 132 recall events; 33 initiated in the last five years and 36 still open. Most recent: 2025-10-27.
| Year | Recalls |
|---|---|
| 2017 | 4 |
| 2018 | 4 |
| 2019 | 8 |
| 2020 | 11 |
| 2021 | 5 |
| 2022 | 8 |
| 2023 | 14 |
| 2024 | 3 |
| 2025 | 6 |
Frequently asked questions
What is FDA product code JAA?
JAA is the FDA product code for system, x-ray, fluoroscopic, image-intensified. It is a Class II device, regulated under 21 CFR 892.1650 and reviewed by the Radiology panel.
What device class is JAA?
Class II, regulation 21 CFR 892.1650. Typical premarket route: 510(k).
How long does a 510(k) take for product code JAA?
Across 300 cleared submissions the average was 89 days from receipt to decision (median 67).
Which companies have the most JAA clearances?
Toshiba America Medical Systems, In.C (13); Siemens Medical Solutions USA, Inc. (10); Fischer Imaging Corp. (10); Shimadzu Medical Systems (10); General Electric Co. (10).
Have JAA devices been recalled?
Yes: 223 product recalls across 132 recall events; the most recent began 2025-10-27.
Next steps
- Run an FDA pathway report with predicate devices for product code JAA
- Run a recall and safety report across every JAA manufacturer
- Watch product code JAA 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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