# K981424: Nomos Bat Ultrasound Localization and Positioning System

- Pathway: 510(k) (Traditional)
- Applicant: Nomos Corp.
- Decided: Jul 17, 1998 after 88 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: 2 generations back to K851659 (1985). 7 ancestors in all.
10 later devices descend from it; 4 cite it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K945957: Ausonics Opus 2 Realtime Ultrasound Scanner, Kleinfeld, Kaplan and Becker (1996) Summary page 1.
- K930506: Therpac Radiotherapy Treatment Planning System, Pinecliff Assoc. (1994) Summary page 1.
- K930295: Patpos Compact, Cp Bio-Medical Corp. (1993) Summary page 1.
- K955397: Mayfield-Acciss Workstation, Nomos Corp. (1996) Summary page 1.

## Most influential descendants
- K032100: I-BEAM (2003), 4 descendants of its own
- K042110: Beamcath (2005), 3 descendants of its own
- K041937: Restitu (2004), 3 descendants of its own
- K111332: Clarity Obp System (2012), 2 descendants of its own
- K131655: Lighthouse (TM) Urinary Catheter (2013), 1 descendant of its own

## Indications for use
BAT can be used for the positioning of all patients that are prescribed external beam radiation treatments to organs which are readily identifiable on ultrasound images.

Source page: https://510kreport.com/device/K981424
Methodology: https://510kreport.com/methodology