# K010591: Olympus EU-C60 Eus Exera Compact Endoscopic Ultrasound Center

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Optical Co., Ltd.
- Decided: Mar 15, 2001 after 15 days
- Product code: ODG (Endoscopic Ultrasound System, Gastroenterology-Urology)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K894632 (1989). 38 ancestors in all.
59 later devices descend from it; 3 cite it directly.
1 of 98 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K994096: Sonoheart Hand-Carried Echocardiography System, Sonosite,Inc. (1999) Summary page 11.
- K961459: Level 10 Hdi, Advanced Technology Laboratories, Inc. (1997) Summary page 11.
- K963023: Ultrasound Gastroscope GF Type UM30P, Olympus America, Inc. (1997) Summary page 11.
- K971660: Olympus GF-UM130 Ultrasound Gastrovideoscope, Its Associated Accessories and Ancillary Equipment, Olympus America, Inc. (1997) Summary page 11.
- K982323: Olympus UM 2R/3R Ultrasonic Probes and Associated Ancillary Equipment, for Bronchial Use, Olympus America, Inc. (1998) Summary page 11.
- K963033: BF 240/P240/IT240 Bronchovideoscope & Accessories, Olympus America, Inc. (1996) Summary page 11.
- K954451: Evis 140 System, Olympus America, Inc. (1996) Summary page 11.
- K961974: FG-36UX, Ultrasound Upper GI Fiberscope, Pentax Precision Instrument Corp. (1997) Summary page 11.
- (no number) SonoSite™ Hand-Carried Ultrasound System: named in the summary without a submission number

## Most influential descendants
- K031347: Ultrasonic Gastrovideoscope, Type UC160P-AT8 and UCT160-AT8 (2003), 44 descendants of its own
- K042140: Olympus BF Type UC160-OL8 (2004), 43 descendants of its own
- K050503: Single Use Aspiration Needle NA-201SX-4022 (2005), 28 descendants of its own
- K063683: Olympus Xeu-M60A Endoscopic Ultrasound Center; XGF-UM180 Ultrasonic Gastrovideoscope (2007), 15 descendants of its own
- K070983: Olympus XBF-UC180F-DT8 Ultrasonic Bronchofibervideoscope Used with Aloka SSD-Alpha 5/10 Ultrasound System (2007), 11 descendants of its own

## Recalls of this device
- Oct 16, 2020 · Class II · Z-0505-2021: A new inspection step was added to the cleaning and disinfection section of the Instructions For Use (IFU) for this device in order to reduce the risk of causing patient infections.
- Oct 16, 2020 · Class II · Z-0506-2021: A new inspection step was added to the cleaning and disinfection section of the Instructions For Use (IFU) for this device in order to reduce the risk of causing patient infections.

## Indications for use
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Source page: https://510kreport.com/device/K010591
Methodology: https://510kreport.com/methodology