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TC2-64B Transcranial Doppler

by Carolina Medical Electronics

510(k) K874684

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK874684 Date25 Apr 1988ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
IYO
Device Class
Class II
Regulation
21 CFR Part 892.1560
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 Oct 2026

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

The Tc2-64b Transcranial Doppler is a pulsed echo ultrasonic medical imaging system. It is classified as a system for imaging and is used in the medical specialty of radiology. The device operates using ultrasound technology to provide imaging capabilities. It is a Class II device.

The Tc2-64b Transcranial Doppler is supplied with a product code of IYO and has been issued a 510(k) clearance, with the decision description being Substantially Equivalent. The device has a clearance type of Traditional and is regulated under 892.1560. It is available in a single model, TC2-64B, and has been assigned the k number K874684.

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