# K123365: Olympus LTF-190-10-3D, Maj-Y0154, Olympus CV-190

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Medical Systems Corp.
- Decided: Mar 1, 2013 after 121 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). 36 ancestors in all.
19 later devices descend from it; 6 cite it directly.
3 of 56 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102379: LTF-Y0009; Maj-YOO41; Xoev-3D1, Olympus Medical Systems Corporation (2011) Summary page 2.
- K111425: Olympus LTF-S190-10, Olumpus Otv-S190, Olympus CLV-S190, Olympus Medical Systems Corp. (2012) Summary page 2.
- K112680: Evis Exera Iii Video System, Olympus Medical Systems Corporation (2012) Summary page 2.

## Most influential descendants
- K150525: SPIES 3D Tip Cam, Image 1 SPIES CCU Image Connect, Image 1 SPIES CCU D-3 Link (2015), 7 descendants of its own
- K201526: TIPCAM1 Rubina Video Endoscope System (2020), 5 descendants of its own
- K193026: Visera Elite II Video System Center, Visera Elite II Endoeye 3D (2020), 5 descendants of its own
- K223759: Arthrex SynergyID Endoscopic Imaging System (2023), 4 descendants of its own
- K201200: Visera Elite II Video System Center (2020), 4 descendants of its own

## Indications for use
This instrument is intended to be used with Olympus video system center, light source, documentation equipment, 3D processor, monitor, hand instruments, electrosurgical unit and other ancillary equipment for endoscopy and endoscopic surgery. This instrument is indicated for use within the thoracic and abdominal cavities including female reproductive organs. This instrument must not be used for observation or treatment of the heart and must not contact the heart or any area near the heart. In addition, this instrument must not come into contact with any device or therapeutic accessory that contacts the heart or any area near the heart. This 3D processor is intended to be used with 3D videoscope and video system center for 3D observation This video system center is intended to be used with Olympus camera heads, endoscopes, light source, monitors, endo-therapy accessories and other ancillary equipment for endoscopic diagnosis, treatment and video observation.

Source page: https://510kreport.com/device/K123365
Methodology: https://510kreport.com/methodology