IYM
8 FDA 510(k) clearances · Product code
41 daysmedian time to decision
211 days90th percentile
8clearances measured
FDA profile
- Official device name
- System, Telethermographic, Infrared
- Device class
- Class III (high risk)
- Regulation
- 21 CFR 884.2980
- Medical specialty
- Obstetrics/Gynecology
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| FMS MODEL 110 (K863736) | Flir Medical Systems | 1986-12-29 |
| VISITHERM (K852950) | C.D. Regelin & Associates, Inc. | 1986-02-07 |
| JEOL MODEL #JTG-500M (K823041) | Jeol | 1982-11-24 |
| DCATS (K812799) | Dorex, Inc. | 1981-10-20 |
| ORTHO-THERM INFRARED SENSOR (K812701) | Orthion Corp. | 1981-10-13 |
| THERMOCOMP (K801553) | Hospital Financial Corp. | 1980-10-31 |
| GRAPHIC STRESS TELETHERMOMETRY (K800491) | Gst Laboratories of Ca, Inc. | 1980-03-04 |
| THERMOGRAPH, MEDICAL (K760999) | Honeywell, Inc. | 1976-11-19 |
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Every clearance here is in the API, with alerts when new ones post.