FDA UDI In Commercial Distribution 🇺🇸 United States

Digital Intraoral X-Ray Sensor

DI: 06970569090559 · Model: CS 6200 · iRay Technology Co. Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Digital Intraoral X-Ray Sensor
Primary DI
06970569090559
Version / Model
CS 6200
Catalog Number
/
Company Name
iRay Technology Co. Ltd.
Labeler DUNS
421363780
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2023-04-26
Public Version
1
Public Version Date
2023-05-04
Public Version Status
New
Public Device Record Key
d663d538-6c34-4434-8fb1-f6ef48dbcbc8

Device Description

The CS 6200 is a USB-driven digital intraoral X-ray sensor based on CMOS technology that is specially designed for acquiring real-time high-quality dental diagnostic images. Image data acquired from the device can be transmitted via a USB 2.0 port to a workstation for display and processing.

Device Characteristics

Single Use
No
Prescription Use (Rx)
Yes
Over the Counter (OTC)
No
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
No
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
No
Has Serial Number
Yes
Has Lot/Batch Number
No
Has Manufacturing Date
Yes
Has Expiration Date
Yes
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
MUH System, X-Ray, Extraoral Source, Digital

GMDN Terms

Code Name
44905 Dental digital imaging sensor, intraoral

Identifiers

Type ID
Primary 06970569090559