# K070983: Olympus XBF-UC180F-DT8 Ultrasonic Bronchofibervideoscope Used with Aloka SSD-Alpha 5/10 Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Medical Systems Corporation
- Decided: Jul 5, 2007 after 90 days
- Product code: PSV (Ultrasound Bronchoscope)
- Device class: 2
- Regulation: 21 CFR 892.1550
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K894632 (1989). 58 ancestors in all.
11 later devices descend from it; 3 cite it directly.
1 of 70 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042140: Olympus BF Type UC160-OL8, Olympus Corporation (2004) Summary page 6.
- K041916: Aloka SSD-Alpha 5 Ultrasound System, Aloka Co. Ltd USA (2004) Summary page 6.
- K043196: Aloka SSD-Alpha 10 Ultrasound System, Aloka Co., Ltd. (2004) Summary page 6.

## Most influential descendants
- K081518: Ultrasound Video Bronchoscope, Model EB-1970UK (2008), 5 descendants of its own
- K131946: Entax Ultrasound Video Bronchoscope EB-1970UK + HI Visin Preirus (2014), 3 descendants of its own
- K183525: EVIS EUS Ultrasound Bronchofibervideoscope Olympus BF-UC190F (2019), 2 descendants of its own
- K203128: Evis Eus Endoscopic Ultrasound Center Olympus EU-ME2/Evis Eus Endoscopic Ultrasound Center Olympus EU-ME2 Premier Plus (2020), 1 descendant of its own
- K183516: PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U (2019), 1 descendant of its own

## Recalls of this device
- Sep 25, 2023 · Class II · Z-0328-2024: Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the poten
- Jul 27, 2023 · Class II · Z-2494-2023: Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large.
- Aug 8, 2018 · Class II · Z-3304-2018: The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have resulted in more applied force than expected and lead to loosening of the instrument channel port.

## Indications for use
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Transesophageal(non-cardiac) Airways and tracheobronchial tree Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Transesophageal(non-cardiac) Airways and tracheobronchial tree

Source page: https://510kreport.com/device/K070983
Methodology: https://510kreport.com/methodology