FDA product code JAO: Scanner, Fluorescent
JAO is the FDA product code for scanner, fluorescent. It is a Class II device, regulated under 21 CFR 892.1220 and reviewed by the Radiology panel. FDA has cleared 2 510(k) submissions under JAO, from 2 different applicants. The average 510(k) review took 80 days (median 80).
Classification
| Field | Value |
|---|---|
| Device name | Scanner, Fluorescent |
| Device class | Class II |
| Regulation | 21 CFR 892.1220 |
| 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 JAO clearance
Top JAO applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Montifore Medical Center | 1 | 1991-08-20 |
| Abiomed, Inc. | 1 | 1990-03-15 |
Most recent JAO clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K911749 | Montifore Medical Center | L-LINEX-RAY FLUORESCENCE | 1991-08-20 | 124 |
| K900574 | Abiomed, Inc. | ABIOMED BODY LEAD ANALYZER MODEL 200/20 | 1990-03-15 | 36 |
Recalls for JAO devices
openFDA lists no recalls for product code JAO.
Frequently asked questions
What is FDA product code JAO?
JAO is the FDA product code for scanner, fluorescent. It is a Class II device, regulated under 21 CFR 892.1220 and reviewed by the Radiology panel.
What device class is JAO?
Class II, regulation 21 CFR 892.1220. Typical premarket route: 510(k).
How long does a 510(k) take for product code JAO?
Across 2 cleared submissions the average was 80 days from receipt to decision (median 80).
Which companies have the most JAO clearances?
Montifore Medical Center (1); Abiomed, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code JAO
- Run a recall and safety report across every JAO manufacturer
- Watch product code JAO 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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