FDA product code IYM: System, Telethermographic, Infrared
IYM is the FDA product code for system, telethermographic, infrared. It is a Class III device, regulated under 21 CFR 884.2980 and reviewed by the Radiology panel. FDA has cleared 8 510(k) submissions under IYM, from 8 different applicants. The average 510(k) review took 64 days (median 30).
Classification
| Field | Value |
|---|---|
| Device name | System, Telethermographic, Infrared |
| Device class | Class III |
| Regulation | 21 CFR 884.2980 |
| Review panel | RA — Radiology |
| Medical specialty | Obstetrics/Gynecology |
| Premarket route | PMA |
Compare with all 510(k) review times · Search every IYM clearance
Top IYM applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Flir Medical Systems | 1 | 1986-12-29 |
| C.D. Regelin & Associates, Inc. | 1 | 1986-02-07 |
| Jeol | 1 | 1982-11-24 |
| Dorex, Inc. | 1 | 1981-10-20 |
| Orthion Corp. | 1 | 1981-10-13 |
3 more applicants have IYM clearances. See the full list in Caduvo.
Most recent IYM clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K863736 | Flir Medical Systems | FMS MODEL 110 | 1986-12-29 | 97 |
| K852950 | C.D. Regelin & Associates, Inc. | VISITHERM | 1986-02-07 | 211 |
| K823041 | Jeol | JEOL MODEL #JTG-500M | 1982-11-24 | 41 |
| K812799 | Dorex, Inc. | DCATS | 1981-10-20 | 14 |
| K812701 | Orthion Corp. | ORTHO-THERM INFRARED SENSOR | 1981-10-13 | 20 |
Recalls for IYM devices
openFDA lists no recalls for product code IYM.
Frequently asked questions
What is FDA product code IYM?
IYM is the FDA product code for system, telethermographic, infrared. It is a Class III device, regulated under 21 CFR 884.2980 and reviewed by the Radiology panel.
What device class is IYM?
Class III, regulation 21 CFR 884.2980. Typical premarket route: PMA.
How long does a 510(k) take for product code IYM?
Across 8 cleared submissions the average was 64 days from receipt to decision (median 30).
Which companies have the most IYM clearances?
Flir Medical Systems (1); C.D. Regelin & Associates, Inc. (1); Jeol (1); Dorex, Inc. (1); Orthion Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code IYM
- Run a recall and safety report across every IYM manufacturer
- Watch product code IYM 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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