# K190404: OTIS Optical Coherence Tomography SYstem

- Pathway: 510(k) (Traditional)
- Applicant: Perimeter Medical Imaging, Inc.
- Decided: Mar 26, 2019 after 35 days
- Product code: NQQ (System, Imaging, Optical Coherence Tomography (Oct))
- Device class: 2
- Regulation: 21 CFR 892.1560
- 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 K944523 (1994). 5 ancestors in all.
1 later device descends 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)
- K171560: OTIS Optical Coherence Tomography System, Perimeter Medical Imaging, Inc. (2017) Summary page 5.

## Most influential descendants
- K203578: OTIS 2.1 Optical Coherence Tomography System, THiA Optical Coherence Tomography System (2021), 0 descendants of its own

## Indications for use
The OTIS 2.0 Optical Coherence Tomography System is indicated for use as an imaging tool in the evaluation of excised human tissue microstructure by providing two-dimensional, cross-sectional, real-time depth visualization, with image review manipulation software for identifying and annotating regions of interest.

Source page: https://510kreport.com/device/K190404
Methodology: https://510kreport.com/methodology