DCATS Telethermographic Infrared System
by Dorex, Inc. 510(k)
Active
510(k) K812799
Overview
The DCATS Telethermographic Infrared System is a Class III medical device classified under FDA regulation 884.2980, designed for telethermographic imaging in obstetrics and gynecology. This system utilizes infrared technology to capture thermal images, enabling non-invasive assessment of physiological parameters related to reproductive health.
This device is supplied as a reusable system and is intended for use in clinical settings where thermal imaging is required for diagnostic purposes. It was cleared under FDA 510(k) K812799 in 1981, with a product code of IYM, and is regulated under the Obstetrics/Gynecology advisory committee. No specific sterility or MRI safety information is provided in the available data.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK812799 | Date20 Oct 1981 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 6 Oct 2026.
Specification
- Full name
- Dcats
- 510(k) Number
- FDA Product Code
- IYM
- Device Class
- Class III
- Regulation
- 21 CFR Part 884.2980
- Advisory Committee
- Obstetrics/Gynecology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Dorex, Inc.
Questions
What clinical areas is the DCATS Telethermographic Infrared System primarily used for?
The DCATS system is designed specifically for obstetrics and gynecology, where it provides non-invasive thermal imaging to assess physiological parameters related to reproductive health. Its infrared technology allows clinicians to capture detailed thermal images for diagnostic evaluation in these specialties.
Is the DCATS system single-use or reusable, and what does that mean for maintenance?
The DCATS is supplied as a reusable system, meaning it is intended for repeated use across multiple patients. Since it is not single-use, proper cleaning, disinfection, and maintenance protocols must be followed to ensure reliability and safety between uses in clinical settings.
How was the DCATS system’s regulatory clearance determined, and which committee reviewed it?
The DCATS received FDA clearance through a traditional 510(k) process, specifically under clearance number K812799, and was deemed substantially equivalent to a predicate device. The Obstetrics/Gynecology advisory committee reviewed the submission, as indicated by the product code IYM and regulatory classification under 884.2980.
Are there any special storage requirements for the DCATS system?
The provided data does not specify any special storage requirements for the DCATS system. However, since it is reusable and designed for clinical use, standard environmental controls (e.g., temperature, humidity) and protection from physical damage should be maintained to preserve its functionality and accuracy.