Novatherm Thermographic Liquid Crystal System
FDA 510(k)Class III (US FDA 510(k))
Identifiers
- 510(k) Number
- K851034 FDA 510(k)
- FDA Product Code
- KXZ FDA 510(k)
Classification
- Device Class
- Class III FDA 510(k)
- Legislation / Framework
- 21 CFR Part 884.2982 FDA 510(k)
- Regulation Number
- 884.2982 FDA 510(k)
- Advisory Committee
- Obstetrics/Gynecology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Novatherm Thermographic Liquid Crystal System is a powered adjunctive device classified as a Thermographic, Liquid Crystal System under FDA regulation 884.2982. It employs liquid crystal technology to measure and visualize body surface temperature, aiding in clinical assessments within obstetrics and gynecology.
This device is intended for single-use or reusable applications in controlled clinical settings, though specific sterility or reuse protocols are not detailed in the submission. It operates as a non-invasive adjunct to diagnostic procedures, with no explicit MRI safety restrictions noted. Supplied as part of a powered system, it requires proper storage to maintain functionality and is authorized under FDA 510(k) clearance (K851034) with a traditional review pathway.
Frequently asked questions
What clinical specialties is the Novatherm Thermographic Liquid Crystal System primarily used in, and how does it assist in assessments?
The Novatherm Thermographic Liquid Crystal System is designed for use in obstetrics and gynecology, where it aids clinical assessments by measuring and visualizing body surface temperature using liquid crystal technology. As a non-invasive adjunctive tool, it provides additional diagnostic insights during procedures in these specialties.
Is the Novatherm system intended for single-use or reusable applications, and what considerations should be taken into account?
The Novatherm system is intended for either single-use or reusable applications in controlled clinical settings, though specific sterility or reuse protocols are not detailed in the submission. Users must follow established infection control guidelines to ensure safe and effective use, particularly if reusing components.
How is the Novatherm system supplied, and what storage requirements should be followed to maintain its functionality?
The Novatherm Thermographic Liquid Crystal System is supplied as part of a powered system, meaning it requires electrical operation. To maintain functionality, proper storage conditions must be followed, though the exact specifications (e.g., temperature, humidity) are not detailed in the submission. Users should refer to the manufacturer’s instructions for optimal storage practices.
What regulatory pathway was used for FDA clearance of the Novatherm system, and what does this mean for its use in clinical settings?
The Novatherm system received FDA 510(k) clearance (K851034) through a traditional review pathway, meaning it was determined to be substantially equivalent to a legally marketed device. This clearance allows its use in clinical settings as an adjunctive diagnostic tool, though clinicians should always follow established protocols and guidelines for its application.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: NOVATHERM - Medtech Products, Inc. Trademark Registration, Medtech Products Inc - Company Profile and News, Medtech Products, Inc. FDA 510 (k) Products - Latest 2024, NOVATHERM (K851034) — FDA 510 (k) | Innolitics, NOVATHERM Trademark - Registration Number 1413212 - Serial Number ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K851034 | Class III | Active |
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Manufacturer
- Manufacturer
- Medtech Products, Inc.
Sources (1)
- FDA 510(k) K851034 24 fields · synced Sep 18, 2026