iQMR - The iQMR is a software package, connected to the - MEDIC VISION - IMAGING SOLUTIONS LTD

Duns Number:514775571

Device Description: The iQMR is a software package, connected to the clinic LAN, that receive and transfer MRI The iQMR is a software package, connected to the clinic LAN, that receive and transfer MRI images.The image processing provide enhanced quality by reducing the image noise level.

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More Product Details

Catalog Number

-

Brand Name

iQMR

Version/Model Number

1.2

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K173605

Product Code Details

Product Code

LLZ

Product Code Name

System, Image Processing, Radiological

Device Record Status

Public Device Record Key

65146918-0678-409f-b690-d23f8c1119ac

Public Version Date

August 19, 2019

Public Version Number

1

DI Record Publish Date

August 11, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MEDIC VISION - IMAGING SOLUTIONS LTD" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 2