# K973622: Transducer Positioner

- Pathway: 510(k) (Traditional)
- Applicant: Protek Medical Products, Inc.
- Decided: Nov 26, 1997 after 64 days
- Product code: ITX (Transducer, Ultrasonic, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 892.1570
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
An ultrasound accessory device used for positioning and guiding an ultrasound transducer probe during volume measurements of the prostate. Used in conjunction with a needle guide grid or radiation seed needle placement for the deposit of seeds.

Source page: https://510kreport.com/device/K973622
Methodology: https://510kreport.com/methodology