# K063683: Olympus Xeu-M60A Endoscopic Ultrasound Center; XGF-UM180 Ultrasonic Gastrovideoscope

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Medical Systems Corporation
- Decided: Feb 8, 2007 after 58 days
- Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1550
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K894632 (1989). 52 ancestors in all.
15 later devices descend from it; 2 cite it directly.
0 of 68 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043275: Olympus EU-M60 Eus Exera Endoscopic Ultrasound Center, Olympus Medical Systems Corporation (2004) Summary page 13.
- K010591: Olympus EU-C60 Eus Exera Compact Endoscopic Ultrasound Center, Olympus Optical Co., Ltd. (2001) Summary page 13.
- K944610: Olympus Ultrasonic Probes, Olympus America, Inc. (1995) Summary page 13.
- K982323: Olympus UM 2R/3R Ultrasonic Probes and Associated Ancillary Equipment, for Bronchial Use, Olympus America, Inc. (1998) Summary page 13.
- K982610: Olympus UM-2R/3R Ultrasonic Probes and Associated Ancillary Equipment (Urinary Tract), Olympus Optical, Co. (1998) Summary page 13.
- K971660: Olympus GF-UM130 Ultrasound Gastrovideoscope, Its Associated Accessories and Ancillary Equipment, Olympus America, Inc. (1997). Our OCR of the scanned summary read K871660, FDA’s number for Western Ragweed Allergen Disc (Incstar Corp.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “GF-UM130 ULTRASONIC GASTROVIDEOSCOPE”.
- K011886: Olympus EU-M60 Eus Exera Endoscopic Ultrasound CTR, Eus Exera Ultrasonic Gastrovideoscope Olympus GF Type UM 160,, Olympus America, Inc. (2001) Summary page 13.
- K051541: GF-UE160-AL5 Ultrasound Endoscope, Olympus America, Inc. (2005) Summary page 13.
- K011314: Olympus GF UC140P-AL5 Ultrasonic Endoscope with Aloka SSD-5500 Ultrasound System, Aloka Co., Ltd. (2001) Summary page 13.
- K012080: SSD-5000 Diagnostic Ultrasound System, Aloka Co., Ltd. (2001) Summary page 13.
- (no number) GF-UM160 Ultrasonic Gastrovideoscope: named in the summary without a submission number

## Most influential descendants
- K092156: Cad 12, Colonoscopy Assist Device (2009), 7 descendants of its own
- K121564: Endoscopic Ultrasound Center EU-Y0006 (2012), 6 descendants of its own
- K100624: Invendo C20 Colonoscopy System (2012), 6 descendants of its own
- K121582: Invendo C25 Colonoscopy System (2012), 5 descendants of its own
- K130058: Endoscopic Ultrasound Center EU-Y0008 (2013), 4 descendants of its own

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

Source page: https://510kreport.com/device/K063683
Methodology: https://510kreport.com/methodology