C22T Ultrasonic Imaging Transducer Probe

Regulatory status

as of registry sync 9 Nov 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number04573596211298 UDI-DI	Date18 Jul 2021Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK191233	Date9 Aug 2019Decided	StatusActive
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK163505	Date30 May 2017Decided	StatusActive
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK160559	Date18 Oct 2016Decided	StatusActive
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK140443	Date16 Jun 2014Decided	StatusActive
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK134016	Date28 Mar 2014Decided	StatusActive

Official records

AccessGUDID record UDI-DI 04573596211298
FDA 510(k) database 510(k) number K191233
FDA 510(k) database 510(k) number K163505
FDA 510(k) database 510(k) number K160559
FDA 510(k) database 510(k) number K140443
FDA 510(k) database 510(k) number K134016

Across registries

2 registries list this device

FDA 510(k) K191233 decided 9 Aug 2019 Active· +4 more in the status table
FDA GUDID UDI-DI 04573596211298 listed 18 Jul 2021 Listed

Recalls

4 recalls · 2 ongoing · FDA

- Ongoing Z-1884-2024 FDA Class II initiated 11 Apr 2024
AC adapters of Noblus can heat up, and cause smoke in the worst case, when an excessive mechanical stress is applied to the socket for power cable (frequent insertion/removal of the power cable).
- Ongoing Z-0189-2022 FDA Class II initiated 14 Oct 2021
Diagnostic ultrasound system with the specified software version and used in conjunction with a Fujifilm (formally Hitachi) transducer does not display the measurement results correctly with two cardiology measurement functions: Mitral Regurgitation Flow (MR Flow) Measurement; Mitral Valve (MV) Measurement. In addition there is an error in the instruction manual.
- Terminated Z-1341-2020 FDA Class II initiated 31 Jan 2020
These 18 probes may have mis-wiring in the inner cables, causing decreased sensitivity and thus resulting in lower peak velocity readings.
- Terminated Z-2090-2017 FDA Class II initiated 2 May 2017
The strength of the arm mounting mechanism was insufficient and had to be redesigned.

Timeline

10 dated events

28 Mar 2014 Cleared FDA 510(k) K134016
16 Jun 2014 Cleared FDA 510(k) K140443
18 Oct 2016 Cleared FDA 510(k) K160559
2 May 2017 Recall initiated FDA recalls Z-2090-2017
30 May 2017 Cleared FDA 510(k) K163505
9 Aug 2019 Cleared FDA 510(k) K191233
31 Jan 2020 Recall initiated FDA recalls Z-1341-2020
18 Jul 2021 Listed FDA GUDID 04573596211298
14 Oct 2021 Recall initiated FDA recalls Z-0189-2022
11 Apr 2024 Recall initiated FDA recalls Z-1884-2024

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Generic name: Surgical ultrasound imaging transducer
Model / reference: C22T

Primary DI / UDI-DI: 04573596211298
510(k) Number: K134016
K140443
K160559
K163505
K191233
FDA product code: IYO, IYN, ITX
GMDN term: Surgical ultrasound imaging transducer

Device class: Class II
Regulation number: 892.1560, 892.1550, 892.1570
GUDID distribution status: In Commercial Distribution

Overview

AI-generated summary, 9 Nov 2026

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

The C22T is a system, imaging, pulsed echo, ultrasonic. This surgical ultrasound imaging transducer is a probe. It must be sterilized before use with liquid chemical, peracetic acid, hydrogen peroxide, ethylene oxide, or high-level disinfectant. The device is stored at temperatures between -10 and 50 Degrees Celsius, 10 to 90 percent relative humidity, and 70 to 106 KiloPascal atmospheric pressure.

The device received 510(k) clearance under submission numbers K134016, K140443, K160559, K163505, and K191233. It is a Class II device. The product codes are IYO, IYN, and ITX. These correspond to regulation numbers 892.1560, 892.1550, and 892.1570.

Category: Surgical ultrasound imaging transducer

Cleared under the same submission (K134016)

and 5 more cleared under K134016

Cleared under the same submission (K140443)

and 2 more cleared under K140443

Similar devices

Also classified as Surgical ultrasound imaging transducer.

HUMANSCAN 5491310 — Humanscan Company, Ltd. Class II
I13C3f Transducer 9076 — Bk Medical ApS Class II
7LT4 Ultrasonic Transducer(FDA) PL1H-30-91142 — Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Class II
HUMANSCAN 5721640 — Humanscan Company, Ltd. Class II
C9150LA — FUJIFILM Healthcare Americas Corporation Class II

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Other devices filed under Surgical ultrasound imaging transducer.

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Questions

AI-generated answers, 9 Nov 2026

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

What is the C22T?

It is recorded under the GMDN device type "Surgical ultrasound imaging transducer", which GMDN defines as "A hand-held ultrasound imaging transducer assembly designed to be positioned within a surgical site for localized intraoperative imaging applications". FDA lists it under the product name "System, Imaging, Pulsed Echo, Ultrasonic". It is recorded as Class II.
What are the product code and regulation of the C22T?

FDA records the C22T under product code IYO and regulation number 892.1560.
Who makes the C22T?

FUJIFILM CORPORATION is the manufacturer on record for the C22T.

Properties

Sterilise before use
Prescription use
Serial number
Manufacturing date

Other properties (11, all answered No)