# K090326: Ret Cam II, Retcam 3 and Retcam Shuttle and Portable Ophthalmic Imaging Systems

- Pathway: 510(k) (Traditional)
- Applicant: Clarity Medical Systems
- Decided: Nov 25, 2009 after 289 days
- Product code: HKI (Camera, Ophthalmic, Ac-Powered)
- Device class: 2
- Regulation: 21 CFR 886.1120
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K081858 (2008). 2 ancestors in all.
7 later devices descend from it; 2 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081858: Retcam 3 Ophthalmic Imaging System, Clarity Medical Systems (2008) Summary page 1.
- K083771: Retcam Portable Ophthalmic Imaging System, Model RCP, Clarity Medical Systems (2009) Summary page 1.

## Most influential descendants
- K102859: Retcam 3 Opthalmic Imaging System (2011), 4 descendants of its own
- K170527: Phoenix Clinical ICON (2017), 3 descendants of its own
- K183059: 3nethra neo (2018), 1 descendant of its own
- K182263: RetCam 3 ; RetCam Shuttle ; RetCam Portable (2018), 1 descendant of its own
- K243600: 3nethra neo HD FA; 3nethra neo HD (2025), 0 descendants of its own

## Recalls of this device
- Jan 24, 2014 · Class II · Z-1154-2014: Software anomaly for RetCam 3, RetCam Shuttle and RetCam Portable with software versions 6.0.x, 6.1. x and 6.2x where the patients age is calculated incorrectly.
- Feb 2, 2012 · Not classified · Z-1099-2012: Still images extracted from video recordings may be mislabeled as to right and left eye.

## Indications for use
Each and all above listed RetCam Systems are indicated for: * 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 I 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 I or 2, with plus disease)* in 35-37 week postmenstrual infants.

Source page: https://510kreport.com/device/K090326
Methodology: https://510kreport.com/methodology