# K182318: Retina Workplace

- Pathway: 510(k) (Traditional)
- Applicant: Carl Zeiss Meditec, Inc.
- Decided: Oct 24, 2018 after 58 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: 10 generations back to K012727 (2002). 52 ancestors in all.
No later device cites it as a predicate yet.
0 of 53 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170638: Retina Workplace, Carl Zeiss Meditec, AG (2017) Summary page 5.
- K150977: Cirrus HD-Oct, Carl Zeiss Meditec, Inc. (2015) Summary page 5.
- K133217: Cirrus Photo, Carl Zeiss Meditec, AG (2014) Summary page 5.
- K122938: Forum Forum Archive Forum Archive & Viewer Forum Assist Match, Carl Zeiss Meditec, AG (2012) Summary page 5.

## Indications for use
The Retina Workplace is a FORUM application intended for processing and displaying fundus image and optical coherence tomography data. It is also intended for generating reports that contain results from optical coherence tomography and fundus photography. The Retina Workplace uses CIRRUS algorithms and normative databases as a quantitative tool for the comparison of macular thickness data to a database of normal subjects. It supports the processing and displaying of CIRRUS OCT-Angiography data, which is indicated as an aid in the visualization of vascular structures of the retina and choroid. The Retina Workplace is intended to aid trained healthcare professionals in the detection, monitoring and management of ocular diseases including, but not limited to, macular holes, cystoid macular edema, diabetic retinopathy and age-related macular degeneration.

Source page: https://510kreport.com/device/K182318
Methodology: https://510kreport.com/methodology