# K042885: Oct-Opthalmoscope

- Pathway: 510(k) (Traditional)
- Applicant: Ophthalmic Technologies, Inc.
- Decided: Jan 21, 2005 after 94 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 K943956 (1994). 1 ancestor in all.
5 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K943956: Retina Tomograph and Flowmeter, Heidelberg Engineering (1994) Summary page 1.

## Cited in the summary but kept off the family tree
- K012727: Humphrey OCT3, Carl Zeiss Ophthalmic Systems, Inc. (2002). Our OCR of the scanned summary read K012727, FDA’s number for Humphrey OCT3 (Carl Zeiss Ophthalmic Systems, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Optical Coherence Tomography Model 3000”. Kept off the family tree.

## Most influential descendants
- K080460: Spectral Oct/Slo (2008), 4 descendants of its own
- 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
- K190732: P200TxE (2019), 0 descendants of its own

## Indications for use
The OTI OCT Ophthalmoscope is intended to offer simultaneous acquisition of high-resolution transversal OCT (Optical Coherence Tomography) and confocal images of the eye fundus. It is indicated in situations where these images are required for diagnosis.

Source page: https://510kreport.com/device/K042885
Methodology: https://510kreport.com/methodology