# K991107: Shadow Trays

- Pathway: 510(k) (Traditional)
- Applicant: Mick Radio-Nuclear Instruments, Inc.
- Decided: Jun 29, 1999 after 89 days
- Product code: IYE (Accelerator, Linear, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5050
- 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 K944315 (1994). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K944315: Blocking Tray, Medtec, Inc. (1994) Summary page 1.

## Most influential descendants
- K023636: Blocking Tray (2002), 0 descendants of its own

## Indications for use
In Radiation Therapy, it is often necessary to create irregularly shaped fields to contour to the desired shape of the treatment volume. Irregular shapes can be achieved by supplementing the shaping ability of the treatment machines collimation system with tertiary beam blocks. These Beam Blocks are used to further collimate and contour the treatment field and are often custom formed from low metling alloys containing lead and other high density metals. In order to be used, beam blocks must be supported in the path of the incident beam so that the resultant treatment field is properly defined at the patient surface. Shadow Trays provide a simple system for holding the blocks in position for treatment with pre-defined geometry.

Source page: https://510kreport.com/device/K991107
Methodology: https://510kreport.com/methodology