SIMSYS - The SIAscope is a quick, non-invasive device for - MedX Health Corp

Duns Number:202128257

Device Description: The SIAscope is a quick, non-invasive device for imaging skin conditions. It uses a techn The SIAscope is a quick, non-invasive device for imaging skin conditions. It uses a technique known as ‘Spectrophotometric Intracutaneous Analysis’ (SIAscopy) to identify and display graphically the separate components of the skin. SIAscopy uses a digital camera and light (both visible and near-infrared) to investigate the skin’s interior structure.The SIAscope operates by illuminating the skin with LEDs and measuring the intensity of remitted light. The intensity of the illumination is similar to the emission from a typical hand held torch or remote control unit. Simsys is an image management system for the Siascope , which in addition to the features of the Molemate software, includes mole and lesion visualization and comprehensive patient image and data storage capabilities.

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More Product Details

Catalog Number

-

Brand Name

SIMSYS

Version/Model Number

V

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K062736,K062736,K062736

Product Code Details

Product Code

PSN

Product Code Name

Light Based Imaging

Device Record Status

Public Device Record Key

b5737861-751d-40c2-be11-b3dd72deeb6c

Public Version Date

October 17, 2018

Public Version Number

4

DI Record Publish Date

September 22, 2016

Additional Identifiers

Package DI Number

10628451918070

Quantity per Package

1

Contains DI Package

00628451918073

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"MEDX HEALTH CORP" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 3