FDA product code JWM: System, Tomographic, Nuclear
JWM is the FDA product code for system, tomographic, nuclear. It is a Class II device, regulated under 21 CFR 892.1310 and reviewed by the Radiology panel. FDA has cleared 17 510(k) submissions under JWM, from 8 different applicants. The average 510(k) review took 78 days (median 52). FDA has posted 1 recall for JWM devices.
Classification
| Field | Value |
|---|---|
| Device name | System, Tomographic, Nuclear |
| Device class | Class II |
| Regulation | 21 CFR 892.1310 |
| 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 JWM clearance
Top JWM applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Siemens Gammasonics, Inc. | 4 | 1991-11-22 |
| Toshiba Medical Systems | 3 | 1985-06-14 |
| General Electric Co. | 3 | 1985-06-06 |
| Adac Laboratories | 2 | 1988-07-18 |
| Medtronic Vascular | 2 | 1978-03-14 |
3 more applicants have JWM clearances. See the full list in Caduvo.
Most recent JWM clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K914350 | Siemens Gammasonics, Inc. | ICON COMPUTER SYSTEM | 1991-11-22 | 56 |
| K904599 | Digital Design, Inc. | D2 SPECTRUM GAMMA CAMERA/CRYSTAL V COMPUTER SYSTEM | 1991-04-23 | 195 |
| K903315 | Siemens Gammasonics, Inc. | ICON | 1991-01-09 | 169 |
| K901545 | Toshiba America Medical Systems, In.C | GCA-9300 NUCLEAR TOMOGRAPHY SYSTEM | 1990-06-26 | 84 |
| K874473 | Adac Laboratories | ADAC MODEL ARC-ST, PC STYLE DATA PROCESSING SYSTEM | 1988-07-18 | 259 |
Recalls for JWM devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2003-02-10.
Frequently asked questions
What is FDA product code JWM?
JWM is the FDA product code for system, tomographic, nuclear. It is a Class II device, regulated under 21 CFR 892.1310 and reviewed by the Radiology panel.
What device class is JWM?
Class II, regulation 21 CFR 892.1310. Typical premarket route: 510(k).
How long does a 510(k) take for product code JWM?
Across 17 cleared submissions the average was 78 days from receipt to decision (median 52).
Which companies have the most JWM clearances?
Siemens Gammasonics, Inc. (4); Toshiba Medical Systems (3); General Electric Co. (3); Adac Laboratories (2); Medtronic Vascular (2).
Have JWM devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2003-02-10.
Next steps
- Run an FDA pathway report with predicate devices for product code JWM
- Run a recall and safety report across every JWM manufacturer
- Watch product code JWM 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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