# K241163: SPECTRALIS with Flex Module

- Pathway: 510(k) (Traditional)
- Applicant: Heidelberg Engineering GmbH
- Decided: Oct 11, 2024 after 168 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: 13 generations back to K012727 (2002). 31 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K223557: SPECTRALIS HRA+OCT and variants, Heidelberg Engineering GmbH (2023) Summary page 6.
- K120057: Envisu Spectral Domain Ophthalmic Imaging System (Sdois), Bioptigen, Inc. (2012) Summary page 6.

## Most influential descendants
- K253837: SPECTRALIS HRA+OCT and variants; SPECTRALIS with Flex Module (2026), 0 descendants of its own

## Indications for use
The SPECTRALIS with Flex Module is a non-contact ophthalmic diagnostic imaging device intended to aid in the visualization of the posterior segment structures of the eye and vasculature of the retina and choroid. SPECTRALIS with Flex Module is intended for imaging of adults and pediatric patients in supine position.

Source page: https://510kreport.com/device/K241163
Methodology: https://510kreport.com/methodology