FDA.reportPublic FDA data

VivoSight

Primary DI
05060507260012
Brand
VivoSight
Company
MICHELSON DIAGNOSTICS LTD
Model
VivoSight Dx
Device 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.
Published
2016-11-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

Code, Name table
CodeName
NQQSystem, Imaging, Optical Coherence Tomography (Oct)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NQQSystem, Imaging, Optical Coherence Tomography (Oct)Radiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K153283000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K153283000VivoSight Dx Topical OCT SystemMichelson Diagnostics, Ltd.2016-08-11NQQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060507260012PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060507260012050605072600125060507260012

GMDN Terms#

Term, Definition table
TermDefinition
Dermatological optical coherence tomography systemAn assembly of devices designed to use a broad-bandwidth light beam aimed via an applicator at a region of interest (ROI) on the surface of the skin for optical coherence tomography (OCT) to provide high-resolution images (e.g., above 3 microns) of the surface tissue in order to visualize skin morphology. It typically consists of a main unit with an operator's console, a computer for image storage, a hand-held probe (applicator), and a visual display unit (VDU). Reflected light is picked up by the probe that converts it into electrical signals. The computer and dedicated software provide cross-sectional images of the derma or two- or three-dimensional (3-D) volume scans.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
349363346
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060507260005VivoSightVivoSight2016-11-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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06975417183872PantherisZylox-Tonbridge Medical Technology Co., Ltd.NQQ2026-03-21
06975417183889PantherisZylox-Tonbridge Medical Technology Co., Ltd.NQQ2026-03-21
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05415067047694Ultreon™LIGHTLAB IMAGING, INC.NQQ2024-03-29
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00851354004509Lightbox L3AVINGER, INC.NQQ2024-01-29
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16932503570050MTMicro-Tech (Nanjing) Co., Ltd.NQQ2023-08-11
16932503570067MTMicro-Tech (Nanjing) Co., Ltd.NQQ2023-08-11