# K181534: Cirrus HD-Oct

- Pathway: 510(k) (Traditional)
- Applicant: Carl Zeiss Meditec, Inc.
- Decided: Feb 15, 2019 after 249 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: 9 generations back to K012727 (2002). 25 ancestors in all.
6 later devices descend from it; 3 cite it directly.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150977: Cirrus HD-Oct, Carl Zeiss Meditec, Inc. (2015) Summary page 4.
- K161194: PLEX Elite 9000 SS-OCT, Carl Zeiss Meditec, Inc. (2016) Summary page 4.

## Most influential descendants
- 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
- K222200: Cirrus HD-Oct (2023), 1 descendant of its own
- K253893: Harmony Referral System with Harmony OCT Viewer (Octave) (2026), 0 descendants of its own
- K252633: Unity DX (Udx) (2025), 0 descendants of its own

## Recalls of this device
- Jan 14, 2022 · Class II · Z-0723-2022: Optic nerve head angiography scan to be turned off due to its distribution without pre-market clearance.
- Jul 8, 2021 · Class II · Z-2227-2021: Due to failure to acquire pre-market clearance for its high resolution tomographic/biomicroscope imaging device (Model 6000) prior to commercializing the device.

## Indications for use
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, corneal epithelium, 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. CIRRUS’ AngioPlex OCT Angiography is indicated as an aid in the visualization of vascular structures of the retina and choroid. (Model 5000 only.) 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/K181534
Methodology: https://510kreport.com/methodology