# K063378: Cirrus HD-Oct, Model 4000

- Pathway: 510(k) (Traditional)
- Applicant: Carl Zeiss Meditec, Inc.
- Decided: Jan 26, 2007 after 79 days
- Product code: HLI (Ophthalmoscope, Ac-Powered)
- 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
No predicates in its family tree.
35 later devices descend from it; 2 cite it directly.
0 of 36 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Stratus OCT with Retinal Nerve Fiber Layer Normative and Macula Database: named in the summary without a submission number
- (no number) Visante OCT: named in the summary without a submission number

## Most influential descendants
- K083291: Cirrus HD-Oct with Retinal Nerve Fiber Layer and Macular Normative Databases, Model 4000 (2009), 29 descendants of its own
- 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

## 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 posterior ocular structures, including retina, retinal nerve fiber layer, macula, and optic disc. 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/K063378
Methodology: https://510kreport.com/methodology