# K112184: Cirrus Photo

- Pathway: 510(k) (Traditional)
- Applicant: Carl Zeiss Meditec, Inc.
- Decided: Jun 18, 2012 after 326 days
- Product code: OBO (Tomography, Optical Coherence)
- Device class: 2
- Regulation: 21 CFR 886.1570
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K012727 (2002). 33 ancestors in all.
13 later devices descend from it; 5 cite it directly.
0 of 47 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052268: Visucam Pro NM, Carl Zeiss Meditec, AG (2005) Summary page 2.
- K083291: Cirrus HD-Oct with Retinal Nerve Fiber Layer and Macular Normative Databases, Model 4000, Carl Zeiss Meditec, Inc. (2009) Summary page 2.
- K111157: CIRRUS HD-OCT WITH RETINAL NERVE FIBER LAYER, MACULAR, OPTIC NERVE HEAD, and GANGLION CELL NORMATIVE DATABASES, Carl Zeiss Meditec, Inc. (2012). Cleared while this submission was under review Summary page 3.
- K011877: FF450 Plus Fundus Camera and Visupac Digital Image Archiving System, or FF450 Plus Visupac System, Carl Zeiss Jena GmbH (2001) Summary page 2.
- K100207: Non-Mydriatic Retinal Camera, Model TRC-NW8F, Topcon Corp. (2010) Summary page 2.
- K092470: Optical Coherence Tomography 3D Oct-2000, Topcon Corp. (2009) Summary page 2.

## Most influential descendants
- K141844: Rescan 700, Callisto Eye (2014), 5 descendants of its own
- K150467: Retina Workplace (2015), 3 descendants of its own
- K133217: Cirrus Photo (2014), 3 descendants of its own
- K180858: CALLISTO eye (2018), 2 descendants of its own
- K170638: Retina Workplace (2017), 2 descendants of its own

## Indications for use
The CIRRUS photo (Models 600 and 800) is a non-contact, high resolution tomographic and biomnicroscopic imaging device that incorporates a digital camera which is suitable for photographing, displaying and storing the data of the retina and surrounding parts of the eye to be examined under mydriatic and non-mydriatic conditions. These photographs support the diagnosis and subsequent observation of eye diseases which can be visually monitored and photographically documented. The CIRRUS photo is indicated for in vivo viewing, axial cross sectional, and three-dimensional imaging and measurement of posterior ocular structures, including retina, retinal nerve fiber layer, macula, and optic disc as well as imaging of anterior ocular structures, including the cornea. It also includes a Retinal Nerve Fiber Layer (RNFL), Optic Nerve Head (ONH), and Macular Normative Database which is a quantitative tool for the comparison of retinal nerve fiber layer, optic nerve head, 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/K112184
Methodology: https://510kreport.com/methodology