Model: WS.7.7
DI: 03665587000187
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: No
OTC: No
First Published: 2026-05-21
Current Version: 2026-05-29
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
de156011-1c1b-428e-a0af-6ed946a1c5c7
Distribution Status:
In Commercial Distribution
DUNS Number:
393382168
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
Yes
Manufacturing Date Tracked:
No
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
03665587000187
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 58473
Name: Diagnostic x-ray digital imaging system workstation application software
Definition:
An individual software application program or group of programs, routines or algorithms that add specific computer assisted display, processing and/or analysis capabilities to a diagnostic x-ray system workstation so that it may function according to its intended purpose, e.g., for the rendering, visualization and manipulation of medical images to support the image display needs of clinicians, diagnosticians and technicians. A basic set of applications programs and routines are included with the multi-purpose diagnostic x-ray system workstation and can be upgraded to correct programming errors or to add new system capabilities.
FDA Product Codes
LLZ
System, Image Processing, Radiological
Premarket Submissions
Submission Number:
K132684
Supplement Number:
000