MICHELSON DIAGNOSTICS LTD

Address:Ground Floor Eclipse House, Eclipse Park,Maidstone Kent,GB

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

System, Imaging, Optical Coherence Tomography (Oct) (NQQ) (2)

Premarket Exempt

Clear

VivoSight - 05060507260005 Catalog Number :

Device Description : The VivoSight Topical OCT system is indicated for use in the two-dimensional, cr The VivoSight Topical OCT system 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, to aid trained and competent clinicians in their assessment of a patient's clinical conditions.

Device Class : 2

Duns Number: 349363346

Premarket Exempt : No

Product Code : NQQ

Prescription Use : Yes

Device Count : 1

VivoSight - 05060507260012 Catalog Number :

Device Description : The VivoSight Dx is indicated for use in the two-dimensional, cross-sectional, r 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.