# K083291: Cirrus HD-Oct with Retinal Nerve Fiber Layer and Macular Normative Databases, Model 4000

- Pathway: 510(k) (Traditional)
- Applicant: Carl Zeiss Meditec, Inc.
- Decided: May 5, 2009 after 179 days
- Product code: OBO (Tomography, Optical Coherence)
- Device class: 2
- Regulation: 21 CFR 886.1570
- 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: 3 generations back to K012727 (2002). 5 ancestors in all.
29 later devices descend from it; 4 cite it directly.
0 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063378: Cirrus HD-Oct, Model 4000, Carl Zeiss Meditec, Inc. (2007) Summary page 1.
- K033123: Stratusoct with RNFL & Macula Normative Database, Carl Zeiss Meditec, Inc. (2004) Summary page 1.
- K051789: Visante Oct, Carl Zeiss Meditec, Inc. (2005)

## Most influential descendants
- K111157: CIRRUS HD-OCT WITH RETINAL NERVE FIBER LAYER, MACULAR, OPTIC NERVE HEAD, and GANGLION CELL NORMATIVE DATABASES (2012), 24 descendants of its own
- K112184: Cirrus Photo (2012), 13 descendants of its own
- K150977: Cirrus HD-Oct (2015), 11 descendants of its own
- K161194: PLEX Elite 9000 SS-OCT (2016), 7 descendants of its own
- K181534: Cirrus HD-Oct (2019), 6 descendants of its own

## Recalls of this device
- Mar 10, 2011 · Not classified · Z-2126-2011: A software defect exists in versions 5.0.0 and 5.1.0 where when following a specific workflow, exam data may be saved under the name of the first patient
- Mar 10, 2011 · Not classified · Z-2127-2011: A software defect exists in versions 5.0.0 and 5.1.0 where when following a specific workflow, exam data may be saved under the name of the first patient

## Indications for use
The CirrusTM HD-OCT is a non-contact, high resolution tomographic and biomicroscopic imaging device. It is indicated for in-vivo viewing, axial cross-sectional, and three-dimensional imaging and measurement of anterior and posterior ocular structures, including cornea, retina, retinal nerve fiber layer, macula, and optic disc. The Cirrus HD-OCT with Retinal Nerve Fiber Layer (RNFL) and Macular Normative Databases is a quantitative tool for the comparison of retinal nerve fiber layer and the macula in the human retina to a database of known normal subjects. 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 holes, cystoid macular edema, diabetic retinopathy, age-related macular degeneration, and glaucoma.

Source page: https://510kreport.com/device/K083291
Methodology: https://510kreport.com/methodology