Xrt 400
510(k) K955414
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK955414 | Date24 Jul 1996 | 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- Withdrawn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, 24 Sep 2026
The Xrt 400 is a radiologic table, a device intended for medical purposes to support a patient during radiologic procedures. It may be fixed or tilting and may be electrically powered.
The Xrt 400 is supplied with FDA 510K authorizations and is classified as a Class II device with special controls. It is used in the field of Radiology and has a product code of KXJ. The device has a registration number and is subject to certain regulations, including 892.1980.
Other devices from Wuestec Medical, Inc.
Questions
AI-generated answers, 24 Sep 2026
What is the XRT 400 used for?
The XRT 400 is used to support patients during radiologic procedures, and may be fixed or tilting, with optional electrical power.
Is the XRT 400 supplied sterile?
The device data does not specify if the XRT 400 is supplied sterile, but it is classified as a Class II device with special controls.
What are the regulatory controls for the XRT 400?
The XRT 400 is subject to regulations, including 892.1980, and has a product code of KXJ, with FDA 510K authorizations.