# K944261: Retina Angiograph

- Pathway: 510(k) (Traditional)
- Applicant: Heidelberg Engineering
- Decided: Nov 14, 1994 after 74 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.
137 later devices descend from it; 1 cites it directly.
0 of 138 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
- K042961: Spy Intra-Operative Imaging System: SP2000 (2005), 136 descendants of its own
- K060867: Spy Intraoperative Imaging System (2006), 134 descendants of its own
- K061871: Leica Model FL800 (2006), 133 descendants of its own
- K071037: Spy Intra-Operative Imaging System, Model SP2000 (2007), 131 descendants of its own
- K063345: Spy Imaging System (2007), 131 descendants of its own

Source page: https://510kreport.com/device/K944261
Methodology: https://510kreport.com/methodology