FDA product code JAM: Scanner, Whole Body, Nuclear
JAM is the FDA product code for scanner, whole body, nuclear. It is a Class I device, regulated under 21 CFR 892.1330 and reviewed by the Radiology panel. FDA has cleared 3 510(k) submissions under JAM, from 3 different applicants. The average 510(k) review took 37 days (median 35).
Classification
| Field | Value |
|---|---|
| Device name | Scanner, Whole Body, Nuclear |
| Device class | Class I |
| Regulation | 21 CFR 892.1330 |
| Review panel | RA — Radiology |
| Medical specialty | Radiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every JAM clearance
Top JAM applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Siemens Gammasonics, Inc. | 1 | 1984-08-27 |
| General Electric Co. | 1 | 1984-07-16 |
| Union Carbide Corp. | 1 | 1977-04-05 |
Most recent JAM clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K842895 | Siemens Gammasonics, Inc. | WBA - I.R.I.S. | 1984-08-27 | 35 |
| K841996 | General Electric Co. | MAXICAMERA 400T W/BODY CONTOUR TOMOGRA | 1984-07-16 | 61 |
| K770530 | Union Carbide Corp. | CLEON IMAGER | 1977-04-05 | 15 |
Recalls for JAM devices
openFDA lists no recalls for product code JAM.
HCPCS codes with matching descriptors
Text match between the FDA device name and CMS descriptors, not an official crosswalk:
- G0219 — Pet imaging whole body; melanoma for non-covered indications
Frequently asked questions
What is FDA product code JAM?
JAM is the FDA product code for scanner, whole body, nuclear. It is a Class I device, regulated under 21 CFR 892.1330 and reviewed by the Radiology panel.
What device class is JAM?
Class I, regulation 21 CFR 892.1330. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JAM?
Across 3 cleared submissions the average was 37 days from receipt to decision (median 35).
Which companies have the most JAM clearances?
Siemens Gammasonics, Inc. (1); General Electric Co. (1); Union Carbide Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code JAM
- Run a recall and safety report across every JAM manufacturer
- Watch product code JAM 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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