# K983999: PANORAMIC200 Opthalmoscope

- Pathway: 510(k) (Traditional)
- Applicant: Optos Plc.
- Decided: Feb 3, 1999 after 86 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: 1 generation back to K871268 (1987). 3 ancestors in all.
13 later devices descend from it; 3 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981640: S2LO, Odyssey Optical Systems, LLC (1998) 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.

## Cited in the summary but kept off the family tree
- K983137: Unnamed device. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1.

## Most influential descendants
- K100644: Optos Limited Panoramic 200CAF (2010), 9 descendants of its own
- 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
- K142897: P200DTx (2015), 5 descendants of its own

## Indications for use
This device is indicated for use as a wide field ophthalmoscope for diagnosing and monitoring diseases or disorders that manifest themselves in the posterior pole of the eye.

Source page: https://510kreport.com/device/K983999
Methodology: https://510kreport.com/methodology