# K042001: Panoramic 200A

- Pathway: 510(k) (Traditional)
- Applicant: Optos Plc.
- Decided: Oct 7, 2004 after 73 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
Longest line of descent: 2 generations back to K871268 (1987). 5 ancestors in all.
9 later devices descend from it; 1 cites it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983999: PANORAMIC200 Opthalmoscope, Optos Plc. (1999) Summary page 1.
- K971671: Heidelberg Retina Angiograph FA/Icga (Hra/C), Heidelberg Engineering (1997) Summary page 1.
- K882517: Rodenstock Scanning Laser Ophthalmoscope, Rodenstock Instrument Corp. (1989) Summary page 1.
- K871268: Rodenstock Scanning Laser Ophthalmoscope, G. Rodenstock Instrumente GmbH (1987) Summary page 1.

## Most influential descendants
- K060424: Panoramic, Model 200MA (2006), 8 descendants of its own
- K102492: P200MAAF (2010), 7 descendants of its own
- K142897: P200DTx (2015), 5 descendants of its own
- K173707: P200TE (2018), 3 descendants of its own
- K231673: P200TE (A10700) (2023), 1 descendant of its own

## Indications for use
This device is indicated for use as a wide field and retinal fluorescence imaging ophithalmoscope to aid in the diagnosis and monitoring of diseases or disorders that manifest themselves in the retina.

Source page: https://510kreport.com/device/K042001
Methodology: https://510kreport.com/methodology