FMS Model 110 Telethermographic Infrared System
by Flir Medical Systems 510(k)
Active
510(k) K863736
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SN | NumberK863736 | Date29 Dec 1986 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 6 Oct 2026.
Specification
- Full name
- Fms Model 110
- 510(k) Number
- FDA Product Code
- IYM
- Device Class
- Class III
- Regulation
- 21 CFR Part 884.2980
- Advisory Committee
- Obstetrics/Gynecology
- FDA Decision
- SN
Overview
AI-generated summary, 18 Sep 2026
The FMS Model 110 is a Telethermographic Infrared System designed for obstetrics and gynecology applications. It employs infrared technology to capture thermal images, enabling non-invasive monitoring of physiological parameters such as skin temperature and blood flow in clinical settings.
This device is supplied as a reusable medical instrument and is intended for use in regulated clinical environments. It requires no sterility as it is not intended for direct patient contact, though proper cleaning and maintenance protocols must be followed. The system is classified under FDA regulation number 884.2980 and was cleared via a Traditional 510(k) pathway (K863736) with a decision date of December 29, 1986.
Questions
AI-generated answers, 18 Sep 2026
What clinical specialties is the FMS Model 110 primarily intended for, and how does it work in those settings?
The FMS Model 110 is designed specifically for obstetrics and gynecology applications. It uses telethermographic infrared technology to capture thermal images non-invasively, allowing clinicians to monitor physiological parameters like skin temperature and blood flow without direct patient contact. This makes it useful for assessing conditions related to vascular health, fetal monitoring, or detecting abnormalities in reproductive organs where traditional methods may be limited.
Is the FMS Model 110 meant for single-use or reusable applications, and what maintenance is required?
The FMS Model 110 is a reusable medical instrument and is not intended for direct patient contact, so it does not require sterility. However, it must be properly cleaned and maintained according to manufacturer guidelines to ensure accurate thermal imaging and longevity. Since it’s not sterile, it’s designed for use in regulated clinical environments where hygiene protocols are strictly followed.
How was the FMS Model 110 approved by the FDA, and what does that mean for its use in clinical settings?
The FMS Model 110 was cleared via a Traditional 510(k) pathway (K863736) under FDA regulation number 884.2980, with a decision date of December 29, 1986. This means it was deemed substantially equivalent to a previously cleared device for some obstetrics/gynecology indications, allowing its use in clinical settings where non-invasive thermal monitoring is beneficial. The approval does not imply it covers all possible applications, so clinicians should confirm its intended use aligns with their specific needs.
What types of physiological parameters can the FMS Model 110 monitor, and why is this technology considered non-invasive?
The FMS Model 110 monitors skin temperature and blood flow using infrared imaging, which detects heat emissions from the body’s surface. This is considered non-invasive because it does not require insertion of instruments, exposure to radiation, or physical contact with sensitive tissues. Instead, it provides real-time thermal data that can help assess perfusion, inflammation, or other vascular-related conditions in obstetrics and gynecology.