Device
NeuroICH is a software-only parallel workflow tool designed for use by hospital networks and trained clinicians to identify and communicate prioritized images of specific patients...
Manufacturer
NEUROCAREAI INC
NEUROCAREAI INC
Model: V1.1.67
DI: 00199874323862
Status: Update
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: No
OTC: No
First Published: 2026-04-24
Current Version: 2026-05-06
Description
NeuroICH is a software-only parallel workflow tool designed for use by hospital networks and trained clinicians to identify and communicate prioritized images of specific patients to an appropriate specialist such as neurovascular or neurosurgical specialist independent of the standard of care workflow.
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
2
Record Key:
9b864af7-9237-43c2-a031-b0531748d19f
Distribution Status:
In Commercial Distribution
DUNS Number:
066723161
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
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:
00199874323862
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
QAS
Radiological Computer-Assisted Triage And Notification Software