# K982446: Dynamic Shielding Radiation Table

- Pathway: 510(k) (Traditional)
- Applicant: American Biophysics, Inc.
- Decided: Sep 29, 1998 after 76 days
- Product code: JAI (Couch, Radiation Therapy, Powered)
- Device class: 2
- Regulation: 21 CFR 892.5770
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K910971 (1991). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K910971: Z XT Radiation Therapy Treatment Table, Siemens Medical Laboratories, Inc. (1991) Summary page 1.

## Indications for use
To be used in treatment where whole body radiation therapy is indicated. The shielding tray reduces the radiation exposure to those organs, such as lungs, which are desired to be shielded.

Source page: https://510kreport.com/device/K982446
Methodology: https://510kreport.com/methodology