# K121993: Spectralis Hra + Oct and Variants, Spectralis FA+ Oct, Spectralis Icga +Oct, Spectralis Oct Blue Peak, Spectralis Oct

- Pathway: 510(k) (Traditional)
- Applicant: Heidelberg Engineering GmbH
- Decided: Oct 25, 2012 after 111 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: 5 generations back to K941234 (1995). 13 ancestors in all.
15 later devices descend from it; 1 cites it directly.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063191: Heidelberg Retina Angiograph 2/Optical Coherence Tomograph, Model Hra 2/Oct, Heidelberg Engineering (2006) Summary page 2.
- K030433: Stratusoct with RNFL Normative Database, Carl Zeiss Meditec, Inc. (2003) Summary page 2.
- K062295: Iri Integrated Retinal Imager, Medivision Medical Imaging, Ltd. (2006) Summary page 2.

## Most influential descendants
- 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
- K181594: Spectralis HRA+OCT and variants with OCT Angiography Module (2018), 8 descendants of its own
- K182569: Spectralis HRA+OCT and variants with High Magnification Module (2018), 7 descendants of its own
- K192391: Spectralis HRA+OCT and Variants (2019), 6 descendants of its own

## Indications for use
The Spectralis HRA±OCT is a non-contact ophthalmic diagnostic imaging device. It is intended for viewing the posterior segment of the eye, including two- and three-dimensional imaging, cross-sectional imaging, fundus photography, and fluorescence imaging (fluorescein, indocyanine green and autofluorescence), and to perform measurements of ocular anatomy and ocular lesions. The device is indicated as an aid in the detection and management of various ocular diseases including: age-related macular degeneration, macular edema, diabetic retinopathy, retinal and choroidal vascular diseases, glaucoma, and for viewing geographic atrophy as well as changes in the eye that result from neurodegenerative diseases. The Spectralis HRA+OCT includes a retinal nerve fiber layer thickness normative database, which is used to quantitatively compare the retinal nerve fiber layer in the human retina to a database of Caucasian normal subjects; the classification result is valid only for Caucasian subjects.

Source page: https://510kreport.com/device/K121993
Methodology: https://510kreport.com/methodology