Model: 3
DI: 00745426000028
Status: Update
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: No
OTC: No
First Published: 2026-04-27
Current Version: 2026-05-08
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
2
Record Key:
9ee772f6-ef77-4fef-ab30-019fa3a87ddf
Distribution Status:
In Commercial Distribution
DUNS Number:
119171303
Device Count:
1
DM Exempt:
No
Premarket Exempt:
Yes
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:
00745426000028
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 41670
Name: Radiological PACS software
Definition:
An individual software application intended to be installed on a central server as part of a picture archiving and communication system (PACS) to allow storage, retrieval, analysis, and management of radiological images.
FDA Product Codes
LMB
Device, Digital Image Storage, Radiological