# K163195: Primus

- Pathway: 510(k) (Traditional)
- Applicant: Carl Zeiss Suzhou Co., Ltd.
- Decided: Jun 21, 2017 after 218 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.
No later device cites it as a predicate yet.
0 of 24 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.

## Indications for use
The PRIMUS instrument is a non-contact, high resolution tomographic and biomicroscopic imaging device. It is indicated for in-vivo viewing of axial cross sections 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/K163195
Methodology: https://510kreport.com/methodology