# K971671: Heidelberg Retina Angiograph FA/Icga (Hra/C)

- Pathway: 510(k) (Traditional)
- Applicant: Heidelberg Engineering
- Decided: Jul 29, 1997 after 83 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.
19 later devices descend from it; 4 cite it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K042001: Panoramic 200A (2004), 9 descendants of its own
- K060424: Panoramic, Model 200MA (2006), 8 descendants of its own
- K102492: P200MAAF (2010), 7 descendants of its own
- K134039: Daytona Icg (P200TICG) (2014), 6 descendants of its own
- K142897: P200DTx (2015), 5 descendants of its own

## Indications for use
Device is intended for viewing the retinal and/or choroidal circulation patterns that are illuminated using fluorescein or indocyanine green dye, and for aiding in the: management of age-related macula degeneration (AMD) detection of choroidal neovascularization (CNV) assessment of diabetic retinopathy assessment of diabetic maculopathy treatment control of diabetic maculopathy, AMD, CNV detection of retinal vascular disturbances assessment of choroidal circulation diagnosis of chorioditis or choroidal diseases

Source page: https://510kreport.com/device/K971671
Methodology: https://510kreport.com/methodology