FDA product code JAB: System, X-Ray, Fluoroscopic, Non-Image-Intensified
JAB is the FDA product code for system, x-ray, fluoroscopic, non-image-intensified. It is a Class II device, regulated under 21 CFR 892.1660 and reviewed by the Radiology panel. FDA has cleared 2 510(k) submissions under JAB, from 2 different applicants. The average 510(k) review took 140 days (median 140).
Classification
| Field | Value |
|---|---|
| Device name | System, X-Ray, Fluoroscopic, Non-Image-Intensified |
| Device class | Class II |
| Regulation | 21 CFR 892.1660 |
| Review panel | RA — Radiology |
| Medical specialty | Radiology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every JAB clearance
Top JAB applicants
| Applicant | Clearances | Latest |
|---|---|---|
| General Robotic Devices, Inc. | 1 | 1997-11-13 |
| Kontron Instruments, Inc. | 1 | 1981-11-24 |
Most recent JAB clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K970782 | General Robotic Devices, Inc. | IMAGING JET SYSTEM | 1997-11-13 | 254 |
| K813032 | Kontron Instruments, Inc. | ZIKON 100 DIGITAL X-RAY SYSTEM | 1981-11-24 | 27 |
Recalls for JAB devices
openFDA lists no recalls for product code JAB.
Frequently asked questions
What is FDA product code JAB?
JAB is the FDA product code for system, x-ray, fluoroscopic, non-image-intensified. It is a Class II device, regulated under 21 CFR 892.1660 and reviewed by the Radiology panel.
What device class is JAB?
Class II, regulation 21 CFR 892.1660. Typical premarket route: 510(k).
How long does a 510(k) take for product code JAB?
Across 2 cleared submissions the average was 140 days from receipt to decision (median 140).
Which companies have the most JAB clearances?
General Robotic Devices, Inc. (1); Kontron Instruments, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code JAB
- Run a recall and safety report across every JAB manufacturer
- Watch product code JAB 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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