# K182263: RetCam 3 ; RetCam Shuttle ; RetCam Portable

- Pathway: 510(k) (Special)
- Applicant: Natus Medical Incorporated
- Decided: Sep 7, 2018 after 17 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: 3 generations back to K081858 (2008). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090326: Ret Cam II, Retcam 3 and Retcam Shuttle and Portable Ophthalmic Imaging Systems, Clarity Medical Systems (2009) Summary page 4.

## Most influential descendants
- K203500: RetCam Envision (2021), 0 descendants of its own

## 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. *References: 1. Cryotherapy for Retinopathy of Prematurity Cooperative Group. Multicenter trial of cryotherapy for retinopathy of prematurity: preliminary results. Archives of Ophthalmology 1988; 106(4):471-479. 2. Early Treatment for Retinopathy of Prematurity Cooperative Group. Revised indications for the treatment of retinopathy of prematurity: results of the Early Treatment for Retinopathy of Prematurity Randomized Trial. Archives of Ophthalmology 2003; 121(12):1684-1694.

Source page: https://510kreport.com/device/K182263
Methodology: https://510kreport.com/methodology