# K261170: BA-004CC

- Pathway: 510(k) (Traditional)
- Applicant: Fujifilm Corporation
- Decided: Aug 12, 2026 after 125 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
Longest line of descent: 3 generations back to K875128 (1988). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222052: VitroPRO, CIVCO Medical Instruments Co., Inc. (2022) Summary page 5.

## Indications for use
This device provides doctors with a tool for performing needle/instrument guided procedures with the use of diagnostic ultrasound probes. It is disposable and provided to the user sterile.

Source page: https://510kreport.com/device/K261170
Methodology: https://510kreport.com/methodology