# K190772: SURGICAL MICROSCOPE SYSTEM ORBEYE with IR

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Medical Systems Corp.
- Decided: Oct 10, 2019 after 198 days
- Product code: IZI (System, X-Ray, Angiographic)
- Device class: 2
- Regulation: 21 CFR 892.1600
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K944261 (1994). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141136: Leica FL800, Leica Biosystems Richmond (2014) Summary page 6.

## Indications for use
This instrument has been designed to be used for viewing intra-operative blood flow in the cerebral vascular area and is intended for use in adults only. This instrument has been designed to be used for viewing intra-operative blood flow in the cerebral vascular area and is intended for use in adults only.

Source page: https://510kreport.com/device/K190772
Methodology: https://510kreport.com/methodology