# K961208: 0.6CC Ionization Chamber - Waterproof 0.6CC Ionization Chamber

- Pathway: 510(k) (Traditional)
- Applicant: Ptw-New York Corp.
- Decided: Jun 17, 1996 after 83 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 K951764 (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)
- K951764: Unidos Universal Dosimeter Model 10002-with TNC Connector, 10005-with BNT Connector, Ptw-New York Corp. (1995) Summary page 1.

## Indications for use
The PTW T30004, T30005, T30001 and T30002 0.6 cc Farmer type ionization chambers are intended to be used for the collection of beam data in water, air, or other suitable solid state phantom material from radiation therapy treatment machines. This data is used to completely document the beam characteristics of treatment machines and to establish and maintain an on going treatment machine quality assurance program.

Source page: https://510kreport.com/device/K961208
Methodology: https://510kreport.com/methodology