FDA.reportPublic FDA data

Digital Intraoral X-Ray Sensor

Primary DI
06970569090559
Brand
Digital Intraoral X-Ray Sensor
Company
iRay Group
Model
CS 6200
Catalog number
/
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.
Published
2023-04-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
MUHSystem, X-Ray, Extraoral Source, Digital

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MUHSystem, X-Ray, Extraoral Source, DigitalDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06970569090559PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06970569090559069705690905596970569090559

GMDN Terms#

Term, Definition table
TermDefinition
Dental digital imaging sensor, intraoralAn analogue device that is temporarily placed in a patient's mouth to perform routine diagnostic dental imaging procedures. It uses analogue-to-digital conversion techniques to record the absorption pattern of x-ray beams used in the diagnosis and treatment of diseases of the jaw or oral cavity structures. The device is used in combination with the x-ray source (x-ray tube) that is located outside the patient's mouth during the imaging procedure; the resulting digital image is transmitted to a monitor or workstation.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
421363780
Device count
1
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06970569090993iRayiScan2026-01-13
06970569090856Digital Intraoral X-ray Imaging SystemXRI-301/2025-08-29
06970569090863Digital Intraoral X-ray Imaging SystemXRI-302/2025-08-29
06970569091006Digital Radiographic Imaging Acquisition Software - DR (RiasDR)RiasDR2025-08-26
06970569091020Wireless Digital Flat Panel DetectorDR10FW2025-06-11
06970569090931Mano4336A Wireless Digital Flat Panel DetectorMano4336A2025-05-13
06970569090948Mano4336F Wireless Digital Flat Panel DetectorMano4336F2025-05-13
06970569090955Mano4343A Wireless Digital Flat Panel DetectorMano4343A2025-05-13
06970569090962Mano4343F Wireless Digital Flat Panel DetectorMano4343F2025-05-13
06970569090979Mano2530A Wireless Digital Flat Panel DetectorMano2530A2025-05-13
06970569090986Mano2530F Wireless Digital Flat Panel DetectorMano2530F2025-05-13
06970569090009Digital flat panel detectorVenu1417C-PSI2016-10-12
06970569090016Digital flat panel detectorVenu1417C-VSI2016-10-12
06970569090023Digital flat panel detectorVenu1417P-PSI2016-10-12
06970569090030Digital flat panel detectorVenu1717M2016-10-12
06970569090047Wireless digital flat panel detectorMars1417V-PSI2016-10-12
06970569090054Wireless digital flat panel detectorMars1417V-TSI2016-10-12
06970569090894Digital Intraoral X-ray Imaging SystemPrime View Ultra 0/2024-10-25
06970569090900Digital Intraoral X-ray Imaging SystemPrime View Ultra 1/2024-10-25
06970569090917Digital Intraoral X-ray Imaging SystemPrime View Ultra 1.5/2024-10-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860011175704A2Z ImagingZINNOVI INC.MUH2026-06-05
00860011175711A2Z ImagingZINNOVI INC.MUH2026-06-05
00860009306110Cleartooth Digital X-RayCLEARTOOTH ELECTRONICS, INC.MUH2026-05-27
08800011200060Dental Digital X-ray Imaging DevicePOINTIMPLANT Co., Ltd.MUH2026-05-21
08800011200084Dental Digital X-ray Imaging DevicePOINTIMPLANT Co., Ltd.MUH2026-05-21
D090101397120IXS S2 Kit, CT, US, FR-CADental Imaging Technologies CorporationMUH2026-05-12
D090101329460DEXIS IXS Size 1 Sensor - RDental Imaging Technologies CorporationMUH2026-04-01
D090101329470DEXIS IXS Size 2 Sensor - RDental Imaging Technologies CorporationMUH2026-04-01
D090800045720DEXIS Ti2 Sensor - R - SDental Imaging Technologies CorporationMUH2026-04-01
D090800045730DEXIS IXS Size 1 Sensor - SDental Imaging Technologies CorporationMUH2026-04-01
D090800045740DEXIS IXS Size 1 Sensor - R - SDental Imaging Technologies CorporationMUH2026-04-01
D090800045750DEXIS IXS Size 2 Sensor - SDental Imaging Technologies CorporationMUH2026-04-01
D090800045760DEXIS IXS Size 2 Sensor - R - SDental Imaging Technologies CorporationMUH2026-04-01
D090800045770DEXIS Ti2 Kit - SDental Imaging Technologies CorporationMUH2026-04-01
D090800045780DEXIS IXS Size 2 Sensor - DDental Imaging Technologies CorporationMUH2026-04-01
D090800045790DEXIS IXS S1 KitDental Imaging Technologies CorporationMUH2026-04-01
D090800045810DEXIS IXS S2 KitDental Imaging Technologies CorporationMUH2026-04-01
D090800045830DEXIS Ti2 Kit - SDental Imaging Technologies CorporationMUH2026-04-01
D090800045840DEXIS Ti2 Kit - R - SDental Imaging Technologies CorporationMUH2026-04-01
D090800045850IXS S1 Warranty Replacement - SDental Imaging Technologies CorporationMUH2026-04-01
D090800045860IXS S1 Warranty Replacement KitDental Imaging Technologies CorporationMUH2026-04-01
D090800045870IXS S2 Warranty NEW KitDental Imaging Technologies CorporationMUH2026-04-01
D090800045880IXS S2 Warranty Replacement KitDental Imaging Technologies CorporationMUH2026-04-01
D090800049760DEXIS Ti2 Sensor - DDental Imaging Technologies CorporationMUH2026-04-01
D090800049770DEXIS IXS Size 1 Sensor - DDental Imaging Technologies CorporationMUH2026-04-01
D090800049790DEXIS Ti2 Kit - DDental Imaging Technologies CorporationMUH2026-04-01
D090800049800DEXIS Ti2 Sensor & Acc. Kit - DDental Imaging Technologies CorporationMUH2026-04-01
D090800049810DEXIS IXS S1 KitDental Imaging Technologies CorporationMUH2026-04-01
D090800049820DEXIS IXS Size 2 KitDental Imaging Technologies CorporationMUH2026-04-01
D090800457100DEXIS Ti2 Sensor - SDental Imaging Technologies CorporationMUH2026-04-01