# K172649: Spectralis HRA + OCT and variants, Spectralis FA+OCT, Spectralis ICGA+OCT, Spectralis OCT Blue Peak, Spectralis OCT with Multicolor

- Pathway: 510(k) (Special)
- Applicant: Heidelberg Engineering GmbH
- Decided: Nov 1, 2017 after 57 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 K941234 (1995). 16 ancestors in all.
13 later devices descend from it; 3 cite it directly.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152205: Spectralis HRA + OCT and variants (e.g.s below), Spectralis FA+OCT, Spectralis ICGA+OCT, Spectralis OCT Blue Peak, Spectralis OCT ith Multicolor, Heidelberg Engineering GmbH (2016) Summary page 5.

## Most influential descendants
- 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
- K201252: Spectralis HRA+OCT and variants (2020), 5 descendants of its own
- K223557: SPECTRALIS HRA+OCT and variants (2023), 4 descendants of its own

## Indications for use
The SPECTRALIS 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 (SPECTRALIS HRA+OCT and SPECTRALIS OCT), fundus photography, fluorescence imaging (fluorescein angiography, indocyanine green angiography; SPECTRALIS HRA+OCT, SPECTRALIS HRA), autofluorescence imaging (SPECTRALIS HRA+OCT, SPECTRALIS HRA and SPECTRALIS OCT with BluePeak) 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 and SPECTRALIS OCT include reference databases for retinal nerve fiber layer thickness and optic nerve head neuroretinal rim parameter measurements, which are used to quantitatively compare the retinal nerve fiber layer and neuroretinal rim in the human retina to values found in normal subjects.

Source page: https://510kreport.com/device/K172649
Methodology: https://510kreport.com/methodology