# K250883: Ultrasonic Probe UM-3R (UM-3R); Ultrasonic Probe UM-G20-29R (UM-G20-29R)

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Medical Systems Corporation
- Decided: Sep 18, 2025 after 178 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: 5 generations back to K926514 (1993). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K231666: Endoscopic Ultrasonic Probe  (P2612S-L); Endoscopic Ultrasonic Probe (P2620S-L), FUJIFILM Healthcare Americas Corporation (2023) Summary page 6.

## Indications for use
The ULTRASONIC PROBE UM-3R has been designed to be used with an Olympus endoscopic ultrasound center, a probe driving unit, other ancillary equipment and an endoscope for intraluminal ultrasonic imaging of the gastrointestinal tract, biliary tract (common bile, cystic, intrahepatic), pancreatic ducts and surrounding organs. This product is intended for use in adults. [Modes of operation] The Mode of Operation is B mode. [Operator qualifications] Appropriately trained healthcare professionals. [Device use settings] Professional healthcare facility (no domestic or special environments) The ULTRASONIC PROBE UM-G20-29R has been designed to be used with an Olympus endoscopic ultrasound center, a probe driving unit, other ancillary equipment and an endoscope for intraluminal ultrasonic imaging of the gastrointestinal tract, biliary tract (common bile, cystic, intrahepatic), pancreatic ducts and surrounding organs. This product is intended for use in adults. [Modes of operation] The Mode of Operation is B mode. [Operator qualifications] Appropriately trained healthcare professionals. [Device use settings] Professional healthcare facility (no domestic or special environments)

Source page: https://510kreport.com/device/K250883
Methodology: https://510kreport.com/methodology