Thermascan Thermographic Liquid Crystal System
510(k) K813547
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK813547 | Date12 Mar 1982 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Full name
- Thermascan
- 510(k) Number
- FDA Product Code
- KXZ
- Device Class
- Class III
- Regulation
- 21 CFR Part 884.2982
- Advisory Committee
- Obstetrics/Gynecology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 20 Sep 2026
The Thermascan is a Thermographic Liquid Crystal System (Device Class 3, Product Code KXZ) designed for adjunctive use in obstetrics and gynecology. It employs liquid crystal technology to detect and visualize temperature variations on the skin’s surface, aiding in the assessment of physiological conditions such as blood flow or thermal asymmetry. This non-invasive, contact-based system provides real-time thermal imaging without ionizing radiation, supporting diagnostic evaluations in specialized medical settings.
Supplied as a reusable device, the Thermascan requires proper calibration and maintenance to ensure accurate thermal readings. It is intended for use in clinical environments where obstetrics and gynecology procedures are performed, adhering to regulatory standards outlined in FDA regulation 884.2982. The system’s liquid crystal foil is designed for direct contact with human skin, with no restrictions on MRI compatibility noted in the submitted data. Storage and handling must comply with manufacturer guidelines to preserve functionality, and its authorization status is confirmed via FDA 510(k) clearance (K813547, granted March 12, 1982)
Other devices from Bcd Products, Inc.
Questions
AI-generated answers, 20 Sep 2026
What clinical specialties is the Thermascan primarily intended for, and how does it assist in patient evaluations?
The Thermascan is designed for adjunctive use in obstetrics and gynecology, where it helps visualize temperature variations on the skin’s surface using liquid crystal technology. By detecting thermal asymmetries or blood flow changes, it supports diagnostic assessments in these specialties without ionizing radiation, providing real-time, non-invasive imaging.
Is the Thermascan a single-use or reusable device, and what maintenance is required to ensure accuracy?
The Thermascan is a reusable device, requiring proper calibration and maintenance to guarantee accurate thermal readings. Since it relies on liquid crystal foil for skin contact, adherence to manufacturer guidelines for cleaning, storage, and periodic servicing is essential to preserve functionality and reliability.
Can the Thermascan be used in environments where MRI compatibility is a concern, and how should it be stored?
The submitted data does not specify MRI restrictions, meaning the Thermascan is not explicitly contraindicated for MRI environments. However, storage must follow manufacturer instructions to maintain performance, as improper handling could affect its thermal imaging capabilities.
What regulatory pathway was followed for FDA clearance, and when was the Thermascan approved?
The Thermascan received FDA 510(k) clearance (K813547) under the Traditional Review pathway, declared substantially equivalent to a predicate device. The decision was made by the Obstetrics/Gynecology (OB) Advisory Committee on March 12, 1982, following submission on December 21, 1981.