# K151011: Visera 4K Uhd System

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Medical Systems Corp.
- Decided: Oct 1, 2015 after 169 days
- Product code: HET (Laparoscope, Gynecologic (And Accessories))
- Device class: 2
- Regulation: 21 CFR 884.1720
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K931154 (1993). 33 ancestors in all.
3 later devices descend from it; 3 cite it directly.
3 of 37 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111425: Olympus LTF-S190-10, Olumpus Otv-S190, Olympus CLV-S190, Olympus Medical Systems Corp. (2012) Summary page 5.
- K102059: Autoclavable Camer Head Model Otv-Y0017, Olympus Medical Systems Corporation (2010) Summary page 5.

## Most influential descendants
- K250551: 4K Endoscopic Camera System (SV-800, SV-800I, SV-800R, SV-800N) (2025), 0 descendants of its own
- K200216: 4K UHD Camera System (2020), 0 descendants of its own
- K172817: 4K Camera Head Olympus CH-S400-XZ-EB, 4K Autoclavable Camera Head Olympus CH-S400-XZ-EA (2017), 0 descendants of its own

## Indications for use
VISERA 4K UHD CAMERA CONTROL UNIT OLYMPUS OTV-S400 The camera control unit has been designed to be used with Olympus endoscopes, camera heads, light source, monitors, and other ancillary equipment for endoscopic diagnosis, treatment, and observation. VISERA 4K UHD XENON LIGHT SOURCE OLYMPUS CLV-S400 The light source has been designed to be used with Olympus endoscopes, camera control unit, light guide cables, and other ancillary equipment for endoscopic diagnosis, treatment, and observation. 4K CAMERA HEAD OLYMPUS CH-S400-XZ-EB The camera head has been designed to be used with Olympus endoscopes, camera control unit, and other ancillary equipment for endoscopic diagnosis, treatment, and observation.

Source page: https://510kreport.com/device/K151011
Methodology: https://510kreport.com/methodology