# K203500: RetCam Envision

- Pathway: 510(k) (Traditional)
- Applicant: Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)
- Decided: Apr 13, 2021 after 134 days
- Product code: HKI (Camera, Ophthalmic, Ac-Powered)
- Device class: 2
- Regulation: 21 CFR 886.1120
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K081858 (2008). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182263: RetCam 3 ; RetCam Shuttle ; RetCam Portable, Natus Medical Incorporated (2018) Summary page 4.

## Indications for use
General ophthalmic imaging including retinal, corneal, and external imaging. * Photodocumentation of pediatric ocular diseases, including retinopathy of prematurity (ROP). * Screening for Type 2 pre-threshold retinopathy of prematurity (ROP) (zone 1, stage 1 or 2, without plus disease, or zone 2, stage 3, without plus disease), or treatment-requiring ROP, defined as Type 1 ROP (zone 1, any stage, with plus disease; zone 1, stage 3 without plus disease; or zone 2, stage 2 or 3, with plus disease), or threshold ROP (at least 5 contiguous or 8 non-contiguous clock hours of stage 3 in zone 1 or 2, with plus disease) * in 35-37 week postmenstrual infants.

Source page: https://510kreport.com/device/K203500
Methodology: https://510kreport.com/methodology