# K912891: Heidelberg Retina Tomograph

- Pathway: 510(k) (Traditional)
- Applicant: Heidelberg Engineering
- Decided: Sep 27, 1991 after 88 days
- Product code: HLI (Ophthalmoscope, Ac-Powered)
- 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
No predicates in its family tree.
5 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K974535: Discam Digital Imaging System (1998), 3 descendants of its own
- K102412: Vista Digital Opthalmoscope (2011), 2 descendants of its own
- K121405: Panoptic (2012), 1 descendant of its own
- K223381: iExaminer System with Panoptic Plus (2023), 0 descendants of its own
- K964137: Rta Retinal Thickness Analyzer (1997), 0 descendants of its own

Source page: https://510kreport.com/device/K912891
Methodology: https://510kreport.com/methodology