# K150977: Cirrus HD-Oct

- Pathway: 510(k) (Traditional)
- Applicant: Carl Zeiss Meditec, Inc.
- Decided: Sep 1, 2015 after 141 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). 23 ancestors in all.
11 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)
- K111157: CIRRUS HD-OCT WITH RETINAL NERVE FIBER LAYER, MACULAR, OPTIC NERVE HEAD, and GANGLION CELL NORMATIVE DATABASES, Carl Zeiss Meditec, Inc. (2012) Summary page 4.
- K051789: Visante Oct, Carl Zeiss Meditec, Inc. (2005) Summary page 4.

## Most influential descendants
- K161194: PLEX Elite 9000 SS-OCT (2016), 7 descendants of its own
- K181534: Cirrus HD-Oct (2019), 6 descendants of its own
- K170638: Retina Workplace (2017), 2 descendants of its own
- K241081: 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1 (type: Maestro2); IMAGEnet6 Ophthalmic Data System (2024), 1 descendant of its own
- K231760: HP-Oct (HP-Oct) (2024), 1 descendant of its own

## Indications for use
The CIRRUS™ HD-OCT is a non-contact, high resolution tomographic and biomicroscopic imaging device intended for in-vivo viewing, axial cross-sectional, and three-dimensional imaging of anterior and posterior ocular structures. The device is indicated for visualizing and measuring anterior and posterior ocular structures, including cornea, retina, retinal nerve fiber layer, ganglion cell plus inner plexiform layer, macula, and optic nerve head. The CIRRUS normative databases are quantitative tools indicated for the comparison of retinal nerve fiber layer thickness, macular thickness, ganglion cell plus inner plexiform layer thickness, and optic nerve head measurements to a database of normal subjects. The CIRRUS OCT angiography is indicated as an aid in the visualization of vascular structures of the retina and choroid. The CIRRUS HD-OCT is indicated 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/K150977
Methodology: https://510kreport.com/methodology