# K083155: HD Camera Head Otv-S7PROH-HD-L08E

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Medical Systems Corporation
- Decided: Jan 13, 2009 after 81 days
- Product code: FET (Endoscopic Video Imaging System/Component, Gastroenterology-Urology)
- Device class: 2
- Regulation: 21 CFR 876.1500
- 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 K955404 (1996). 1 ancestor in all.
11 later devices descend from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K955404: Otv-S5 Oes Video System, Olympus America, Inc. (1996) Summary page 2.

## Most influential descendants
- K102059: Autoclavable Camer Head Model Otv-Y0017 (2010), 10 descendants of its own
- K190449: Visera Elite II Video System Center, Visera Elite II HD 3CMOS Autoclavable Camera Head, Visera Elite II 3CMOS Camera Head (2019), 5 descendants of its own
- K151011: Visera 4K Uhd System (2015), 3 descendants of its own
- K242067: Visera Elite Iii Video System Center Olympus Otv-S700; Visera Elite Iii Led Light Source Olympus CLL-S700; 4K Camera Head Olympus CH-S700-XZ-EA (2025), 2 descendants of its own
- K262079: 4K Camera Head OLYMPUS CH-S700-08-LB (2026), 0 descendants of its own

## Indications for use
This camera head has been designed to be used with the CV-180 EXERA II video system center or O!V-S7Pro VISERA Pro video system center, endoscopes, light sources, video monitors and other ancillary equipment for endoscopic diagnosis and treatment within the bladder, urethra, ureter, and kidney.

Source page: https://510kreport.com/device/K083155
Methodology: https://510kreport.com/methodology