AccessGUDID - DEVICE: iQMR (07290016836400)

GUDID

Device Identifier (DI) Information

Brand Name: iQMR
Version or Model: 1.2
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: MEDIC VISION - IMAGING SOLUTIONS LTD

Primary DI Number: 07290016836400
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 514775571 *Terms of Use

Device Description: 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.

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
40872	MRI system application software	An individual software program or group of programs, routines or algorithms that add specific image processing and/or analysis capabilities to a magnetic resonance imaging (MRI) system configuration. A basic set of applications programs and routines are included with such computer-controlled imaging systems and they can be upgraded to correct programming errors or to add new system capabilities. Some applications software programs or program packages must be combined with specific hardware or firmware configurations in order to function as intended. Applications program packages are typically identified by a proprietary name and "version" or "upgrade" number.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LLZ	System, Image Processing, Radiological

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K173605	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

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