TBI Stand
by Mick Radio-Nuclear Instruments, Inc.
510(k) K972709
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK972709 | Date16 Oct 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- Withdrawn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
- IYE
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.5050
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 27 Sep 2026
The TBI Stand is a medical device used to safely support and reposition a patient for radiation therapy treatment in the vertical position when a physician desires to treat the patient with whole body irradiation by high energy photons. It is classified as an Accelerator, Linear, Medical device with product code IYE.
The TBI Stand is supplied by Mick Radio-Nuclear Instruments, Inc. and is a Class II device under special controls. It received FDA 510(k) clearance with number K972709 on October 16, 1997, after a review period of 87 days. The device is intended for use in radiology settings for whole body irradiation treatments.
Other devices from Mick Radio-Nuclear Instruments, Inc.
Questions
AI-generated answers, 27 Sep 2026
What is the TBI Stand used for?
The TBI Stand is a medical device designed to safely support and reposition patients for radiation therapy treatment in the vertical position when physicians need to administer whole body irradiation using high energy photons.
How is the TBI Stand supplied?
The TBI Stand is supplied by Mick Radio-Nuclear Instruments, Inc. It is a Class II medical device under special controls, intended for use in radiology settings for whole body irradiation treatments.
What is the regulatory status of the TBI Stand?
The TBI Stand received FDA 510(k) clearance with number K972709 on October 16, 1997, after an 87-day review period. It is classified as an Accelerator, Linear, Medical device with product code IYE.
Is the TBI Stand reusable or single-use?
The device data does not specify whether the TBI Stand is reusable or single-use. For specific usage instructions and disposal guidelines, please consult the manufacturer's documentation or contact Mick Radio-Nuclear Instruments, Inc.