Model: RAYMO
DI: 08800011150129
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-05-20
Current Version: 2026-05-28
Description
Power Specification :100-240V~ / 125kV
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
e07b8321-d147-4c4a-a174-7d670be76786
Distribution Status:
In Commercial Distribution
DUNS Number:
688477319
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
No
Serial Number Tracked:
Yes
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
08800011150129
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 37647
Name: Mobile basic diagnostic x-ray system, digital
Definition:
An assembly of devices that comprise a digital general-purpose mobile diagnostic x-ray system used in a variety of routine planar x-ray imaging applications. It uses digital techniques for image capture, display and manipulation and the mobile design allows it to operate on mains or battery power and to be driven or pushed by an operator to various locations within a building or facility. It is commonly used for bedside imaging and for interventional and intraoperative imaging. It consists of basic modular configurations that can be upgraded. This GMDN code does not cover systems with fluoroscopic or tomographic capabilities.
FDA Product Codes
IZL
System, X-Ray, Mobile
MQB
Solid State X-Ray Imager (Flat Panel/Digital Imager)
Premarket Submissions
Submission Number:
K260085
Supplement Number:
000