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S-Series OCT

Perimeter Medical Imaging AI, Inc. · Model PMI001OCT21 · UDI-DI 00754016215049

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510(k) clearances

Adverse events

Recalls

Facilities

Description

The OTIS 2.1 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. Perimeter’s OTIS 2.1 cart assembly encloses an OCT-based imaging system and has a touchscreen monitor.

Recalls

Date	Firm	Reason
2018-04-11	Ninepoint Medical Inc.	Distal tips of the probes may detach from the probe shaft during use.
2011-12-22	Imalux Corporation	During an FDA inspection, the firm was notified that the wrong tubing was used during the manufacture of the probe for the unit.
2010-07-20	Optovue Inc.	Use of the CAM attachment may result in a positioning anomaly and mistreatment in the eyes of the patient.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.