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Tetrad TC-C3-ACP

by Tetrad Corp.

510(k) K002193

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 NumberK002193 Date4 May 2001ClearedStatusActive

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  • Withdrawn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
ITX
Device Class
Class II
Regulation
21 CFR Part 892.1570
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 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 Tetrad TC-C3-ACP is an ultrasound system classified under product code ITX. It is a Class II medical device used in radiology.

The device received FDA 510(k) clearance under K-number K002193 on May 4, 2001, and is substantially equivalent to a predicate device. It is manufactured by Tetrad Corp. and supplied as a non-sterile, reusable system for use in clinical radiology settings.

Other devices from Tetrad Corp.

Questions

AI-generated answers, 23 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 clinical setting is the TETRAD TC-C3-ACP intended for?

    It is designed for use in radiology departments, providing clinicians with an ultrasound platform that meets the imaging needs of routine diagnostic examinations in that specialty.

  • Is the system supplied sterile or ready for reuse?

    The device is supplied non‑sterile and is intended to be reused after appropriate cleaning and disinfection according to the manufacturer’s instructions, which is typical for Class II imaging equipment.

  • What regulatory pathway did the TETRAD TC-C3-ACP follow?

    It received traditional FDA 510(k) clearance, demonstrating substantial equivalence to a predicate device, and was assigned K‑number K002193 on May 4 2001.

  • Can the TETRAD TC-C3-ACP be used for multiple patients?

    Yes, because it is a reusable system, it can be employed for many patients after each use is properly reprocessed; this reuse capability helps reduce overall equipment costs in a clinical radiology setting.