Device
QP-Brain® is a medical imaging processing application intended for automatic labeling and volumetric quantification of segmentable brain structures and white matter hyperintensitie...
Manufacturer
QUIBIM SOCIEDAD LIMITADA.
QUIBIM SOCIEDAD LIMITADA.
Model: 1.0
DI: 08437021468045
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-05-06
Current Version: 2026-05-14
Description
QP-Brain® is a medical imaging processing application intended for automatic labeling and volumetric quantification of segmentable brain structures and white matter hyperintensities (WMH) from a set of adults and adolescents 18 and older MR images. Volumetric measurements may be compared to reference percentile data. The application is used by clinicians with proper training, as a support tool in assessment of structural MRIs. Patient management decisions should not be based solely on the results of the device.
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
65dfd8c8-99c5-4f08-9cb5-00404ef5d28d
Distribution Status:
In Commercial Distribution
DUNS Number:
464843370
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
Yes
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
08437021468045
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
QIH
Automated Radiological Image Processing Software
LLZ
System, Image Processing, Radiological
Premarket Submissions
Submission Number:
K232231
Supplement Number:
000