# K063191: Heidelberg Retina Angiograph 2/Optical Coherence Tomograph, Model Hra 2/Oct

- Pathway: 510(k) (Traditional)
- Applicant: Heidelberg Engineering
- Decided: Oct 31, 2006 after 11 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: 1 generation back to K012727 (2002). 1 ancestor in all.
43 later devices descend from it; 2 cite it directly.
0 of 45 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012727: Humphrey OCT3, Carl Zeiss Ophthalmic Systems, Inc. (2002) Summary page 1.

## Most influential descendants
- K101223: Spectralis Hra+Oct, Spectralis FA_Oct, Spectralis Icga+ Oct, Spectralis Hra, Spectralis FA (2010), 41 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
- K121993: Spectralis Hra + Oct and Variants, Spectralis FA+ Oct, Spectralis Icga +Oct, Spectralis Oct Blue Peak, Spectralis Oct (2012), 15 descendants of its own
- K152205: Spectralis HRA + OCT and variants (e.g.s below), Spectralis FA+OCT, Spectralis ICGA+OCT, Spectralis OCT Blue Peak, Spectralis OCT ith Multicolor (2016), 14 descendants of its own
- K172649: Spectralis HRA + OCT and variants, Spectralis FA+OCT, Spectralis ICGA+OCT, Spectralis OCT Blue Peak, Spectralis OCT with Multicolor (2017), 13 descendants of its own

## Indications for use
The OCT add-on to the HRA 2 is intended for use for the imaging of the retina and retinal structures, and for aiding in the assessment and management of various diseases of the posterior segment, such like age-related macula degeneration, diabetic retinopathy, and glaucoma.

Source page: https://510kreport.com/device/K063191
Methodology: https://510kreport.com/methodology