Radius Cf
510(k) K894547
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK894547 | Date22 Nov 1989 | 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- Withdrawn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
- ITX
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.1570
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 26 Sep 2026
The Radius Cf is a diagnostic ultrasonic transducer. This device is designed for use in radiology applications.
This device is a Class II medical device that received FDA 510(k) clearance on November 22, 1989. It is manufactured by General Electric Co. and is identified by product code ITX.
Other devices from General Electric Co.
Questions
AI-generated answers, 26 Sep 2026
What is the intended use of the Radius Cf?
The Radius Cf is a diagnostic ultrasonic transducer specifically designed for use in radiology applications to assist clinicians in imaging procedures.
Who is the manufacturer of the Radius Cf transducer?
The device is manufactured by General Electric Co., based in Milwaukee, Wisconsin.
What is the regulatory status of this device?
The Radius Cf is a Class II medical device that received FDA 510(k) clearance on November 22, 1989, under the K-number K894547, and is classified under product code ITX.