RADKOR, RF-159
by Radkor, Inc.
510(k) K883885
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK883885 | Date19 Oct 1988 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- KXJ
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.1980
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 23 Sep 2026
The RADKOR, RF-159 is a radiologic table used for medical imaging procedures. It is designed to support patients during radiological examinations, providing a stable platform for imaging equipment.
The device is supplied by Radkor, Inc. and has FDA 510K clearance with the product code KXJ. It is a Class II medical device regulated under 892.1980, intended for use in radiology settings.
Other devices from Radkor, Inc.
Questions
AI-generated answers, 23 Sep 2026
What is the RADKOR RF-159 used for?
The RADKOR RF-159 is a radiologic table designed to support patients during radiological examinations, providing a stable platform for imaging equipment in radiology settings.
How is the RADKOR RF-159 supplied?
The device is supplied by Radkor, Inc. and has FDA 510K clearance with the product code KXJ. It is a Class II medical device regulated under 892.1980.
What is the regulatory status of the RADKOR RF-159?
The RADKOR RF-159 has FDA 510K clearance with the product code KXJ. It is a Class II medical device regulated under 892.1980 and was determined to be substantially equivalent.
Is the RADKOR RF-159 reusable or single-use?
The device data does not specify whether the RADKOR RF-159 is designed for single-use or multiple uses. For specific usage instructions, please consult the manufacturer's documentation.