FDA product code JAI: Couch, Radiation Therapy, Powered
JAI is the FDA product code for couch, radiation therapy, powered. It is a Class II device, regulated under 21 CFR 892.5770 and reviewed by the Radiology panel. FDA has cleared 32 510(k) submissions under JAI, 1 in the last five years, from 22 different applicants. The average 510(k) review took 105 days (median 76); 340 days on average over the last three years. FDA has posted 18 recalls for JAI devices, 2 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Couch, Radiation Therapy, Powered |
| Device class | Class II |
| Regulation | 21 CFR 892.5770 |
| Review panel | RA — Radiology |
| Medical specialty | Radiology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for JAI
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 51 |
| 2019 | 1 | 274 |
| 2024 | 1 | 340 |
Compare with all 510(k) review times · Search every JAI clearance
Top JAI applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Medical Intelligence Medizintechnik GmbH | 3 | 2007-10-25 |
| Nomos Corp. | 3 | 2001-12-07 |
| Forte Automation Systems, Inc. | 2 | 2017-04-13 |
| Med-Tec, Inc. D/B/A Civco Medical Solutions | 2 | 2013-09-26 |
| Brainlab AG | 2 | 2012-06-29 |
17 more applicants have JAI clearances. See the full list in Caduvo.
Most recent JAI clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K231612 | Leo Cancer Care | Eve Patient Positioner System | 2024-05-07 | 340 |
| K182683 | Chinan Biomedical Technology, Inc. | Z-Robot Patient Positioning System | 2019-06-27 | 274 |
| K170502 | Forte Automation Systems, Inc. | Patient Positioning System | 2017-04-13 | 51 |
| K160518 | Leoni Cia Cable System | LEONI ORION System | 2016-07-14 | 141 |
| K132084 | Med-Tec, Inc. D/B/A Civco Medical Solutions | PROTURA COUCH SOFTWARE | 2013-09-26 | 83 |
Recalls for JAI devices
18 product recalls in 17 recall events; 2 initiated in the last five years and 2 still open. Most recent: 2023-10-06.
| Year | Recalls |
|---|---|
| 2017 | 2 |
| 2018 | 1 |
| 2023 | 2 |
Frequently asked questions
What is FDA product code JAI?
JAI is the FDA product code for couch, radiation therapy, powered. It is a Class II device, regulated under 21 CFR 892.5770 and reviewed by the Radiology panel.
What device class is JAI?
Class II, regulation 21 CFR 892.5770. Typical premarket route: 510(k).
How long does a 510(k) take for product code JAI?
Across 32 cleared submissions the average was 105 days from receipt to decision (median 76).
Which companies have the most JAI clearances?
Medical Intelligence Medizintechnik GmbH (3); Nomos Corp. (3); Forte Automation Systems, Inc. (2); Med-Tec, Inc. D/B/A Civco Medical Solutions (2); Brainlab AG (2).
Have JAI devices been recalled?
Yes: 18 product recalls across 17 recall events; the most recent began 2023-10-06.
Next steps
- Run an FDA pathway report with predicate devices for product code JAI
- Run a recall and safety report across every JAI manufacturer
- Watch product code JAI 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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