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VivoSight

MICHELSON DIAGNOSTICS LTD · Model VivoSight Dx · UDI-DI 05060507260012

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510(k) clearances

Adverse events

Recalls

Facilities

Description

The VivoSight Dx is indicated for use in the two-dimensional, cross-sectional, real-time imaging of external tissues of the human body. This indicated use allows imaging of tissue microstructure including skin, and enables detection and display of regions within the scanned area that are in motion (Dynamic OCT) to aid trained and competent clinicians in their assessment of a patient's clinical conditions.

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.