CTS-285 with EZU-PL21 and EZU-PC3B Transducers
by Shantou Institute of Ultrasonic Instuments
510(k) K963065
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK963065 | Date29 May 1997 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 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
The device is a System, Imaging, Pulsed Echo, Ultrasonic medical device as defined by its classification name. It is substantially equivalent to a predicate device and was cleared via the traditional 510(k) pathway.
It was manufactured by Shantou Institute of Ultrasonic Instruments and received FDA 510(k) clearance under K963065 on May 29, 1997. The device is classified under product code IYO and falls within the Radiology specialty.
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Questions
AI-generated answers, 6 Oct 2026
What is the CTS-285 with EZU-PL21 and EZU-PC3B transducers used for?
The CTS-285 system is a pulsed echo ultrasonic imaging device intended for general radiology applications, as indicated by its product code IYO and classification under the Radiology specialty, allowing visualization of internal body structures using sound waves.
How was the CTS-285 with EZU-PL21 and EZU-PC3B transducers cleared for market?
The device received FDA 510(k) clearance through the traditional pathway under K963065 on May 29, 1997, demonstrating substantial equivalence to a legally marketed predicate device, which is the standard regulatory route for moderate-risk medical devices in the U.S.
Who manufactures the CTS-285 with EZU-PL21 and EZU-PC3B transducers and where is it located?
The system is manufactured by Shantou Institute of Ultrasonic Instruments, with the applicant listed as the same entity, located at 1106 Chiltern Dr., Walnut Creek, CA 94596, United States, as recorded in the FDA 510(k) database.