Model: 2
DI: 00754016387128
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-05-14
Current Version: 2026-05-22
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
d08b62a8-18d7-4601-ac0e-fc2da9402805
Distribution Status:
In Commercial Distribution
DUNS Number:
203306964
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:
Yes
Identifiers
Device ID:
00754016387128
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
QIH
Automated Radiological Image Processing Software
LLZ
System, Image Processing, Radiological
Premarket Submissions
Submission Number:
K252298
Supplement Number:
000