Model: 3
DI: 00745426000042
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:
a67b24d6-ecd6-4a78-a729-97a3a3a3606c
Distribution Status:
In Commercial Distribution
DUNS Number:
119171303
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:
No
Identifiers
Device ID:
00745426000042
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 44087
Name: Radiology information system application software
Definition:
An application software program, routines, and/or algorithms used as or in a radiology information system (RIS) to electronically receive, collect, store, manage, assist in analysis of, display, output, and distribute data, within/between facilites, to support the administrative and clinical activities associated with the provision and utilization of radiology services and facilities. It may be used for patient scheduling and work-list generation for specific radiological systems; it may be used in conjunction with PACS and include various technology imaging modalities. It is installed into a dedicated radiology information system or existing mainframe or decentralized computers/network.
FDA Product Codes
LLZ
System, Image Processing, Radiological
Premarket Submissions
Submission Number:
K212984
Supplement Number:
000