# K111628: P200T

- Pathway: 510(k) (Special)
- Applicant: Optos Plc.
- Decided: Aug 19, 2011 after 70 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: 3 generations back to K871268 (1987). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100644: Optos Limited Panoramic 200CAF, Optos Plc. (2010) Summary page 1.

## Indications for use
The Panoramic 200T scanning laser ophthalmoscope is intended to be used as a wide field and retinal autofluorescence imaging ophthalmoscope to aid in the diagnosis and monitoring of diseases or disorders that manifest in the retina.

Source page: https://510kreport.com/device/K111628
Methodology: https://510kreport.com/methodology