# K200516: OCT-Camera ID 21101A3

- Pathway: 510(k) (Traditional)
- Applicant: Optomedical Technologies GmbH
- Decided: Sep 2, 2020 after 184 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: 6 generations back to K012727 (2002). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142953: OCT-Camera, Optomedical Technologies GmbH (2015) Summary page 5.

## Indications for use
OptoMedical Technologies OCT-Camera ID 21101A3 is intended to acquire, process, display and save depth-resolved images of ocular tissue microstructure using Spectral Domain Optical Coherence Tomography (SD-OCT). The OCT-Camera ID 21101A3 is indicated for the use as an aid in the diagnosis of physiologic and pathologic conditions of the eye through non-contact optical imaging. Imaging of the various tissues of the eye is supported through the use of interchangeable lenses. It is indicated for use on all patient populations except premature and neonatal infants, and is suitable for patients ambulatory or confined. The system is indicated for use in supine imaging, mounted to the surgical microscope HS Hi‐R NEO 900A NIR (Haag‐Streit), and is suited for imaging patients under anesthesia.

Source page: https://510kreport.com/device/K200516
Methodology: https://510kreport.com/methodology