# K191615: Huvitz Imaging System

- Pathway: 510(k) (Special)
- Applicant: Huvitz Co., Ltd.
- Decided: Jul 18, 2019 after 30 days
- Product code: NFJ (System, Image Management, Ophthalmic)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K896095 (1990). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161829: Huvitz Imaging System, Huvitz Co., Ltd. (2017) Summary page 4.

## Indications for use
Huvitz Imaging system (HIS-5000U) is intended for controlling digital imaging devices and for acceptance, transfer, display, storage and digital processing of documentation ophthalmic images and videos, acquired from a slit lamp camera through a direct connection to a PC or to multiple PCs via a local network.

Source page: https://510kreport.com/device/K191615
Methodology: https://510kreport.com/methodology