# K142423: EyeSuite Imaging

- Pathway: 510(k) (Traditional)
- Applicant: Haag-Streit AG
- Decided: Sep 10, 2014 after 13 days
- Product code: NFJ (System, Image Management, Ophthalmic)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K896095 (1990). 10 ancestors in all.
2 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)
- K082364: Imagenet Professional PC Software System or Imagenet Professional, or Imagenet Pro, or Digital Imaging Software for, Topcon Corp. (2008) Summary page 5.
- K013694: Nidek Advanced Vision Information System (Navis), Nidek, Inc. (2002) Summary page 4.

## Most influential descendants
- K161829: Huvitz Imaging System (2017), 1 descendant of its own
- K191615: Huvitz Imaging System (2019), 0 descendants of its own

## Recalls of this device
- Jan 5, 2017 · Class II · Z-1500-2017: There is a possibility for data to be stored under the wrong patient on the DICOM Server following a non-standard workflow.

## Indications for use
EyeSuite Imaging is a software program intended for use for controlling digital imaging devices and for acceptance, transfer, display, storage and digital processing of documentational ophthalmic images and videos, acquired from computerized diagnostic instruments, through direct connection or through networks. EyeSuite Basic is a patient and examination management system, acting as a base and communication platform for other EyeSuite software components.

Source page: https://510kreport.com/device/K142423
Methodology: https://510kreport.com/methodology