Model: 1.7
DI: G713ELU0010
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-05-07
Current Version: 2026-05-15
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
92801a37-c9f5-42df-b8ad-e53ca25e95bd
Distribution Status:
In Commercial Distribution
DUNS Number:
204914249
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:
Yes
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
G713ELU0010
Type:
Primary
Issuing Agency:
HIBCC
GMDN
Code: 60724
Name: Multidisciplinary medical image management software
Definition:
A software application intended to be used to receive, collect, store, and display a broad range of medical imaging and/or video data, and to distribute the data within or between healthcare facilities to facilitate data analysis, organization, reporting, and sharing (e.g., teaching); it might be designed for holographic viewing of three-dimensional (3-D) images in conjunction with an appropriate headset or for real-time communication of diagnostic/surgical images, and might also enable the control of light settings of a device (e.g., microscope) for image acquisition.
FDA Product Codes
LLZ
System, Image Processing, Radiological
Premarket Submissions
Submission Number:
K220649
Supplement Number:
000