# K070611: Bat Ultrasound Localization and Positioning System, Version 6

- Pathway: 510(k) (Traditional)
- Applicant: Nomos Corp.
- Decided: Jul 11, 2007 after 128 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
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
BAT can be used for the positioning of patients that are prescribed external beam radiation treatments to organs which are readily identifiable on ultrasound images. BAT can be used for general imaging for small organs (breast, thyroid, testes), abdominal, trans-esophageal (non-cardiac), trans-rectal, trans-vaginal, and musculo-skeletal (superficial and conventional) applications.

Source page: https://510kreport.com/device/K070611
Methodology: https://510kreport.com/methodology