ELC-Thermo-System
by Cutter Laboratories, Inc. 510(k)
Active
510(k) K770678
Overview
The ELC-Thermo-System is a Thermographic, Liquid Crystal, Powered System (Adjunctive Use) classified under FDA regulation 884.2982. This device employs liquid crystal technology to visualize thermal patterns, aiding in the assessment of physiological temperature variations in obstetrics and gynecology.
Intended for single-use or reusable applications (as specified in clinical protocols), the ELC-Thermo-System is designed for use in obstetric and gynecologic settings. Supplied sterile or non-sterile based on clinical requirements, it operates as an adjunct to diagnostic procedures and must comply with FDA 510(k) clearance (K770678). No MRI safety information is provided, and storage conditions follow manufacturer guidelines for liquid crystal-based devices.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK770678 | Date25 May 1977 | 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- Withdrawn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
- 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
Other devices from Cutter Laboratories, Inc.
Questions
What clinical specialties is the ELC-Thermo-System primarily intended for, and how does it function in those settings?
The ELC-Thermo-System is designed for use in obstetrics and gynecology settings. It employs liquid crystal technology to visualize thermal patterns, helping clinicians assess physiological temperature variations as an adjunct to diagnostic procedures. This aids in identifying subtle temperature differences that may correlate with underlying conditions, though it is not a standalone diagnostic tool.
Is the ELC-Thermo-System meant for single-use or reusable applications, and how should it be handled based on sterility needs?
The ELC-Thermo-System is flexible for single-use or reusable applications, depending on clinical protocols. Sterility is configurable based on requirements—it can be supplied either sterile or non-sterile to align with procedural needs. Always follow manufacturer guidelines for preparation, handling, and reprocessing if reused.
What regulatory pathway does the ELC-Thermo-System follow, and what does its classification under FDA regulation 884.2982 imply?
The ELC-Thermo-System follows the FDA 510(k) clearance pathway (K770678) and is classified under FDA regulation 884.2982, categorized as a Thermographic, Liquid Crystal, Powered System (Adjunctive Use). Its classification as Class III (via the provided OpenFDA data) historically required premarket approval, though this device was deemed substantially equivalent to a predicate, allowing clearance via the traditional 510(k) process.
Are there any special storage instructions for the ELC-Thermo-System, particularly given its liquid crystal components?
The ELC-Thermo-System requires adherence to manufacturer-specified storage guidelines for liquid crystal-based devices. These typically include protection from extreme temperatures, humidity, and direct sunlight to preserve functionality. Always refer to the included instructions or contact Cutter Laboratories for precise conditions, as improper storage could degrade performance.