# K972804: Bang Polymer Gel Dosimeter, Bang 533

- Pathway: 510(k) (Traditional)
- Applicant: Mgs Research, Inc.
- Decided: Oct 23, 1997 after 87 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 K945321 (1995). 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)
- K945321: Wellhofer WP700 V. 3.2, Medical Physics Instrumentation, Inc. (1995) Summary page 1.

## Indications for use
Polymer-gel dosimeters may be used for quality assurance procedures for radiotherapy treatments whenever three dimensional dose distributions are required. They can be used for routine measurements of radiation dose distributions produced by irradiation devices delivering doses in the range 0-30 Gy.

Source page: https://510kreport.com/device/K972804
Methodology: https://510kreport.com/methodology