FDA product code JAD: System, Therapeutic, X-Ray
JAD is the FDA product code for system, therapeutic, x-ray. It is a Class II device, regulated under 21 CFR 892.5900 and reviewed by the Radiology panel. FDA has cleared 53 510(k) submissions under JAD, 4 in the last five years, from 33 different applicants. The average 510(k) review took 119 days (median 95); 265 days on average over the last three years. FDA has posted 12 recalls for JAD devices, 3 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | System, Therapeutic, X-Ray |
| Device class | Class II |
| Regulation | 21 CFR 892.5900 |
| Review panel | RA — Radiology |
| Medical specialty | Radiology |
| Premarket route | 510(k) |
510(k) clearances per year for JAD
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 81 |
| 2018 | 1 | 141 |
| 2019 | 2 | 82 |
| 2022 | 1 | 25 |
| 2023 | 1 | 129 |
| 2025 | 2 | 265 |
Compare with all 510(k) review times · Search every JAD clearance
Top JAD applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Xoft, Inc. | 5 | 2009-07-16 |
| Sensus Healthcare, Inc. | 3 | 2019-02-21 |
| Icad, Inc. | 3 | 2016-02-25 |
| Sensus Healthcare | 3 | 2015-10-16 |
| Carl Zeiss Surgical GmbH | 3 | 2012-04-13 |
28 more applicants have JAD clearances. See the full list in Caduvo.
Most recent JAD clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K250692 | Voxel Ray Solutions, LLC | GentleBeam (GB1000) | 2025-12-03 | 271 |
| K241174 | Carl Zeiss Meditec, AG | INTRABEAM (700); And accessories (INTRABEAM SMART Stand, INTRABEAM SMART Spherical Applicator, INTRABEAM Spherical Sizer Set, INTRABEAM Needle Applicator) | 2025-01-10 | 259 |
| K230611 | Xstrahl, Ltd. | X80 / RADiant / PhotoElectric Therapy System (RADiant Aura) | 2023-07-13 | 129 |
| K213942 | Nucletron B.V. | Esteya | 2022-01-11 | 25 |
| K190255 | Sensus Healthcare, Inc. | Sensus Healthcare TVM Balloon Applicator | 2019-02-21 | 14 |
Recalls for JAD devices
12 product recalls in 9 recall events; 3 initiated in the last five years and 2 still open. Most recent: 2026-06-01.
| Year | Recalls |
|---|---|
| 2017 | 1 |
| 2021 | 2 |
| 2022 | 1 |
| 2023 | 1 |
| 2026 | 1 |
Frequently asked questions
What is FDA product code JAD?
JAD is the FDA product code for system, therapeutic, x-ray. It is a Class II device, regulated under 21 CFR 892.5900 and reviewed by the Radiology panel.
What device class is JAD?
Class II, regulation 21 CFR 892.5900. Typical premarket route: 510(k).
How long does a 510(k) take for product code JAD?
Across 53 cleared submissions the average was 119 days from receipt to decision (median 95).
Which companies have the most JAD clearances?
Xoft, Inc. (5); Sensus Healthcare, Inc. (3); Icad, Inc. (3); Sensus Healthcare (3); Carl Zeiss Surgical GmbH (3).
Have JAD devices been recalled?
Yes: 12 product recalls across 9 recall events; the most recent began 2026-06-01.
Next steps
- Run an FDA pathway report with predicate devices for product code JAD
- Run a recall and safety report across every JAD manufacturer
- Watch product code JAD 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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