Tetrad TC-C3-ACP

FDA 510(k) K002193 · Tetrad Corp.

Substantially Equivalent

510(k) numberK002193

Submission

Device name
Tetrad TC-C3-ACP
Applicant
Tetrad Corp.
Englewood, CO, US
Received
July 20, 2000
Decision date
May 4, 2001
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
ITX – Transducer, Ultrasonic, Diagnostic
Device class
Class II (moderate risk)
Regulation
21 CFR 892.1570
Specialty
Radiology

Other 510(k)s with product code ITX

510(k)DeviceApplicantDecision
K261170BA-004CCITX · Traditional Fujifilm Corporation08/12/2026SE
K254143EM-TECH Passive Ultrasound Probe StrapITX · Traditional EM-TECH Solutions, Inc.08/10/2026SE
K260161SmartGuide Disposable Guides and GridsITX · Traditional UC-CARE , Ltd.07/30/2026SE
K262474ND Needle Guidance SystemITX · Traditional Accurate Access, LLC07/27/2026SE
K261014Accuro® 3S Needle Guide KitITX · Traditional Rivanna Medical, Inc.07/24/2026SE
K250883Ultrasonic Probe UM-3R (UM-3R); Ultrasonic Probe UM-G20-29R (UM-G20-29R)ITX · Traditional Olympus Medical Systems Corporation09/18/2025SE
K250762Ultrasonic Probe UM-S20-17S (UM-S20-17S); Ultrasonic Probe UM-S20-20R (UM-S20-20R)ITX · Traditional Olympus Medical Systems Corporation07/11/2025SE
K250524Mendaera Guidance SystemITX · Traditional Mendaera, Inc.07/02/2025SE
K250469Accuro® 3S Needle Guide KitITX · Traditional Rivanna Medical, Inc.06/13/2025SE
K241662Ultrasound Transducer CoverITX · Traditional Vitrolife Sweden AB08/30/2024SE

More from Vitrolife Sweden AB

510(k)DeviceDecision
K042620Sonata 3-D Imaging Accessory, Model 3DSIYO · Traditional 12/23/2004SE
K014182Tetrad Model TC-C52-, -C84V-, -C95-, -CLA76-, -L74-ATP TransducersITX · Traditional 01/03/2002SE
K013849Tetrad Model TC-EC7-ACP, -L5-, -L7-, -V4-ACP TransducersITX · Traditional 12/03/2001SE

Questions and answers

When was Tetrad TC-C3-ACP cleared by the FDA?

Tetrad TC-C3-ACP (K002193) received a 510(k) decision of Substantially Equivalent on May 4, 2001, 288 days after the submission was received.

What is the product code of K002193?

The FDA product code is ITX – Transducer, Ultrasonic, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 892.1570.