# K222200: Cirrus HD-Oct

- Pathway: 510(k) (Traditional)
- Applicant: Carl Zeiss Meditec, Inc.
- Decided: Apr 13, 2023 after 262 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: 10 generations back to K012727 (2002). 26 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181534: Cirrus HD-Oct, Carl Zeiss Meditec, Inc. (2019) Summary page 5.

## Most influential descendants
- K233933: CIRRUS™ HD-OCT Model 6000 (2024), 0 descendants of its own

## 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. CIRRUS’ AngioPlex OCT Angiography is indicated as an aid in the visualization of vascular structures of the retina and choroid. 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/K222200
Methodology: https://510kreport.com/methodology