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Thermocomp Telethermographic Infrared System

by Hospital Financial Corp.

510(k) K801553

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK801553 Date31 Oct 1980ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

Full name
Thermocomp
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

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Thermocomp Telethermographic Infrared System is a Class III medical device classified under FDA regulation 884.2980, designed for telethermographic imaging in obstetrics and gynecology. It employs infrared technology to capture thermal data, enabling non-invasive monitoring of physiological parameters relevant to these specialties.

This device is supplied as a reusable system and requires FDA 510(k) clearance (K801553) for use in clinical settings. It is intended for professional medical environments and adheres to regulatory standards established for telethermographic systems. No specific sterility or MRI safety information is provided in the available data.

Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What specialties is the Thermocomp Telethermographic Infrared System primarily used for in clinical settings?

    The Thermocomp is designed specifically for use in obstetrics and gynecology, leveraging infrared technology to capture thermal data for non-invasive monitoring of physiological parameters relevant to these fields. Its classification under FDA regulation 884.2980 and advisory committee designation (OB) confirm its focus on these specialties.

  • Is the Thermocomp system reusable or single-use, and what does that mean for maintenance?

    The Thermocomp is supplied as a reusable system, meaning it is intended for repeated use in clinical settings after proper cleaning and maintenance. Since it is not sterile, its reuse requires adherence to manufacturer guidelines for disinfection and upkeep to ensure safety and performance between patient encounters.

  • How is the Thermocomp system regulated by the FDA, and what does that mean for purchasing or using it?

    The Thermocomp holds an FDA 510(k) clearance (K801553) under the Traditional review pathway, classified as Substantially Equivalent to a predicate device. This means it has been evaluated and approved for use in professional medical environments, but purchasers or users should confirm compliance with the manufacturer’s instructions and any additional facility-specific protocols to ensure proper operation.

  • What types of thermal imaging capabilities does the Thermocomp provide, and how might that benefit clinicians?

    The Thermocomp uses telethermographic infrared technology to capture thermal data non-invasively, allowing clinicians to monitor physiological parameters in obstetrics and gynecology. While the exact imaging specifics (e.g., resolution, temperature range) aren’t detailed here, its design enables remote or long-distance thermal assessment, which can aid in diagnostic or monitoring workflows without direct patient contact.