Device
GIQuant is a post processing application which uses image registration to quantify motion in abdominal image data obtained from MR systemsto assist physicians in performing special...
Manufacturer
MOTILENT LIMITED
MOTILENT LIMITED
Model: 1.5.5
DI: 05060896890005
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-05-11
Current Version: 2026-05-19
Description
GIQuant is a post processing application which uses image registration to quantify motion in abdominal image data obtained from MR systemsto assist physicians in performing specialized measurements and analysis. GIQuant is integrated within a DICOM compliant workflow server and the output is compatible with software developed in accordance with the DICOM standard.
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
f0bad402-650f-4f82-b55d-7f6c94237deb
Distribution Status:
In Commercial Distribution
DUNS Number:
219686311
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
No
Serial Number Tracked:
No
Manufacturing Date Tracked:
No
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
05060896890005
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 57812
Name: Radiology DICOM image processing application software
Definition:
A software application intended to facilitate management, distribution, and/or viewing of radiological digital imaging and communications in medicine (DICOM) image data; it is not intended for pathological image interpretation (i.e., not intended to detect and localize suspected abnormalities). It may be intended to facilitate image management (e.g., viewing, communication, printing, recording/disc burning) and/or image quality manipulation and quantification (e.g., non-interpretive graphical overlays).
FDA Product Codes
LLZ
System, Image Processing, Radiological
Premarket Submissions
Submission Number:
K211356
Supplement Number:
000