# K231666: Endoscopic Ultrasonic Probe  (P2612S-L); Endoscopic Ultrasonic Probe (P2620S-L)

- Pathway: 510(k) (Traditional)
- Applicant: FUJIFILM Healthcare Americas Corporation
- Decided: Dec 13, 2023 after 189 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: 4 generations back to K926514 (1993). 7 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K994103: Olympus UM-S30-25R Ultrasonic Probe and Associated Ancillary Equipment for Gastrointestinal Tract, Olympus America, Inc. (2000) Summary page 4.

## Most influential descendants
- K250883: Ultrasonic Probe UM-3R (UM-3R); Ultrasonic Probe UM-G20-29R (UM-G20-29R) (2025), 0 descendants of its own
- K250762: Ultrasonic Probe UM-S20-17S (UM-S20-17S); Ultrasonic Probe UM-S20-20R (UM-S20-20R) (2025), 0 descendants of its own

## Indications for use
This product is a medical ultrasonic probe. It is intended for the observation and diagnosis of the gastrointestinal tract and surrounding organs under the management of physicians at medical facilities. This product is intended for adults. Modes of Operation: B-mode Never use this product for any other purposes.

Source page: https://510kreport.com/device/K231666
Methodology: https://510kreport.com/methodology