# K982323: Olympus UM 2R/3R Ultrasonic Probes and Associated Ancillary Equipment, for Bronchial Use

- Pathway: 510(k) (Traditional)
- Applicant: Olympus America, Inc.
- Decided: Dec 11, 1998 after 162 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: 2 generations back to K926514 (1993). 4 ancestors in all.
142 later devices descend from it; 8 cite it directly.
6 of 147 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K951994: Olympus EU-M30 Endoscopic Ultrasound Center, Olympus America, Inc. (1996) Summary page 1.
- K944610: Olympus Ultrasonic Probes, Olympus America, Inc. (1995) Summary page 1.
- K926514: Endoscopic Ultrasound System Type 20, Olympus Corp. (1993) Summary page 1.
- K882061: Olympus GF-UM3/EU-M3, Olympus Corp. (1988) Summary page 1.

## Most influential descendants
- K042438: Superdimension/Bronchus (2004), 73 descendants of its own
- K011886: Olympus EU-M60 Eus Exera Endoscopic Ultrasound CTR, Eus Exera Ultrasonic Gastrovideoscope Olympus GF Type UM 160, (2001), 60 descendants of its own
- K010591: Olympus EU-C60 Eus Exera Compact Endoscopic Ultrasound Center (2001), 59 descendants of its own
- K052260: Superdimension/Bronchus 4.1 (2005), 56 descendants of its own
- K052852: Superdimension/Bronchus Premium (2005), 55 descendants of its own

## Indications for use
Olympus UM-2R and UM-3R Ultrasonic Probes have been designed for use in conjunction with Olympus Endoscopic Ultrasound System for intraluminal sonographic imaging of the upper airways and tracheobronchial tree.

Source page: https://510kreport.com/device/K982323
Methodology: https://510kreport.com/methodology