# K030433: Stratusoct with RNFL Normative Database

- Pathway: 510(k) (Traditional)
- Applicant: Carl Zeiss Meditec, Inc.
- Decided: May 1, 2003 after 80 days
- Product code: HLI (Ophthalmoscope, Ac-Powered)
- Device class: 2
- Regulation: 21 CFR 886.1570
- 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: 1 generation back to K012727 (2002). 1 ancestor in all.
89 later devices descend from it; 5 cite it directly.
0 of 91 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012727: Humphrey OCT3, Carl Zeiss Ophthalmic Systems, Inc. (2002)

## Most influential descendants
- K033123: Stratusoct with RNFL & Macula Normative Database (2004), 77 descendants of its own
- K063343: Bioptigen Spectral Domain Ophthalmic Imaging System (2006), 70 descendants of its own
- K071250: CA, Model: Cam (2007), 64 descendants of its own
- K101505: Rtvue Model Rtvue 100 (2010), 58 descendants of its own
- K101223: Spectralis Hra+Oct, Spectralis FA_Oct, Spectralis Icga+ Oct, Spectralis Hra, Spectralis FA (2010), 41 descendants of its own

## Recalls of this device
- Jul 31, 2009 · Not classified · Z-2048-2009: Mis-labeled image. A bug in version 6.0.0 software and 6.0.0 software kit used with Stratus OCT Model 3000 can produce a report that incorrectly labels OD or OS.

## Indications for use
The STRATUSOCT is a high resolution tomographic device for the viewing and axial cross sectional imaging of posterior ocular structures. It is used for in vivo imaging and measurement of the retina, retinal nerve fiber layer, and optic disk. It is intended for use as a diagnostic device to aid in the detection and management of ocular diseases, including but not limited to macular edema, central serous retinopathy, and glaucoma. The STRATUSOCT with Retinal Nerve Fiber Layer ("RNFL") Normative Database is a quantitative tool for the comparison of retinal nerve fiber layer in the human retina to a database of known normal subjects. The RNFL Normative Database is intended for use as a diagnostic aid in the detection and management of ocular diseases, especially glaucoma.

Source page: https://510kreport.com/device/K030433
Methodology: https://510kreport.com/methodology