Visitherm Telethermographic Infrared System
by C.D. Regelin & Associates, Inc. 510(k)
Active
510(k) K852950
Overview
The Visitherm Telethermographic Infrared System is a telethermographic infrared device designed for non-invasive temperature monitoring. Classified under the nomenclature for obstetrics/gynecology, it employs infrared technology to capture thermal images, enabling clinical assessment of surface temperature patterns.
This system is intended for use in obstetric and gynecologic settings, supplied as a reusable medical device. It operates under FDA clearance (510K, K852950) and adheres to regulatory standards for Class III devices (Regulation Number 884.2980). Proper calibration and maintenance are required for accurate thermal imaging, with storage conditions specified by the manufacturer to preserve functionality.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK852950 | Date7 Feb 1986 | 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- Withdrawn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
- Visitherm
- 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
Questions
What clinical settings is the Visitherm Telethermographic Infrared System primarily used in, and how does it work?
The Visitherm is designed for use in obstetric and gynecologic settings. It employs infrared technology to capture thermal images of a patient’s surface, allowing clinicians to assess temperature patterns non-invasively. This helps in evaluating conditions related to blood flow, inflammation, or other physiological changes without direct contact.
Is the Visitherm a single-use or reusable device, and what maintenance is required to ensure accuracy?
The Visitherm is a reusable medical device. To maintain accuracy, it requires proper calibration and regular maintenance as specified by the manufacturer. Adhering to these guidelines ensures reliable thermal imaging performance over time.
What regulatory pathway was followed for FDA clearance of the Visitherm, and what classification does it hold?
The Visitherm received FDA clearance through a traditional 510(k) pathway (K852950) and is classified as a Class III device under regulation number 884.2980. The decision was based on substantial equivalence to a predicate device, with review by the Obstetrics/Gynecology advisory committee.
How should the Visitherm be stored to preserve its functionality and imaging capabilities?
The manufacturer specifies storage conditions to maintain the device’s functionality. While exact details aren’t provided here, typical guidelines for reusable infrared systems include protection from extreme temperatures, humidity, and physical damage. Always follow the manufacturer’s instructions to ensure optimal performance.