# K142897: P200DTx

- Pathway: 510(k) (Traditional)
- Applicant: Optos Plc.
- Decided: Jan 16, 2015 after 105 days
- Product code: MYC (Ophthalmoscope, Laser, Scanning)
- 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: 5 generations back to K871268 (1987). 10 ancestors in all.
5 later devices descend from it; 3 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K134039: Daytona Icg (P200TICG), Optos Plc. (2014) Summary page 7.
- K102492: P200MAAF, Optos Plc. (2010) Summary page 7.

## Most influential descendants
- K173707: P200TE (2018), 3 descendants of its own
- K231673: P200TE (A10700) (2023), 1 descendant of its own
- K233602: P200TE (A10700) (2024), 0 descendants of its own
- K221320: Scanning Laser Ophthalmoscope Mirante [SLO/OCT Model] with Image Filing Software NAVIS-EX; Scanning Laser Ophthalmoscope Mirante [SLO Model] with Image Filing Software NAVIS-EX (2023), 0 descendants of its own
- K190732: P200TxE (2019), 0 descendants of its own

## Indications for use
The P200DTx scanning laser ophthalmoscope is indicated for use as a widefield and retinal fluorescence and autofluorescence imaging ophthalmoscope to aid in the diagnosis and monitoring of diseases and disorders that manifest in the retina.It is also indicated for use as a widefield scanning laser ophthalmoscope for viewing choroidal circulation patterns that are illuminated using Indocyanine Green dye and for aiding in both the assessment of choroidal circulation and in the diagnosis of choroiditis or choroidal diseases.

Source page: https://510kreport.com/device/K142897
Methodology: https://510kreport.com/methodology