# K951994: Olympus EU-M30 Endoscopic Ultrasound Center

- Pathway: 510(k) (Traditional)
- Applicant: Olympus America, Inc.
- Decided: Apr 15, 1996 after 353 days
- Product code: IYO (System, Imaging, Pulsed Echo, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K926514 (1993). 1 ancestor in all.
148 later devices descend from it; 7 cite it directly.
6 of 150 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K926514: Endoscopic Ultrasound System Type 20, Olympus Corp. (1993) Summary page 1.
- (no number) Aloka SSD-550 Ultrasound System: named in the summary without a submission number

## Most influential descendants
- K982323: Olympus UM 2R/3R Ultrasonic Probes and Associated Ancillary Equipment, for Bronchial Use (1998), 142 descendants of its own
- K042438: Superdimension/Bronchus (2004), 73 descendants of its own
- K982610: Olympus UM-2R/3R Ultrasonic Probes and Associated Ancillary Equipment (Urinary Tract) (1998), 67 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

## Indications for use
Olympus EU-M30 Endoscopic Ultrasound center is designed to be used in combination with the Olympus GF-UM20/JF-UM20/CF-UM20 ultrasonic endoscopes, Olympus UM-2R/UM-3R ultrasonic probes, and Olympus MH-908 esophageal ultrasonic probe for observation of real-time, ultrasonic images of upper GI tract, lower GI tract, and adjacent structures.

Source page: https://510kreport.com/device/K951994
Methodology: https://510kreport.com/methodology