SKANRAY TECHNOLOGIES LIMITED

Address:Plot# 15-17, Hebbal Industrial Area,Mysore Karnataka,IN

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) (MWI) (4) Unit, X-Ray, Extraoral With Timer (EHD) (2) System, Measurement, Blood-Pressure, Non-Invasive (DXN) (2) System, X-Ray, Mobile (IZL) (2) System, X-Ray, Stationary (KPR) (1) Image-Intensified Fluoroscopic X-Ray System, Mobile (OXO) (1) Interventional Fluoroscopic X-Ray System (OWB) (1) Solid State X-Ray Imager (Flat Panel/Digital Imager) (MQB) (1)

Premarket Exempt

Clear

Imagescan HD - 08904269400583 Catalog Number :

Device Description : Imagescan HD with 33" Straight arm is High Frequency Extra oral X-Ray source to Imagescan HD with 33" Straight arm is High Frequency Extra oral X-Ray source to be used for Intra oral X-Ray in DentalRadiography for diagnostic purpose

Device Class : 2

Duns Number: 863358955

Premarket Exempt : No

Product Code : EHD

Prescription Use : Yes

Device Count : 1

Imagescan HD - 08904269400590 Catalog Number :

Device Description : Imagescan HD Floor stand is High Frequency Extra oral X-Ray source to be used fo Imagescan HD Floor stand is High Frequency Extra oral X-Ray source to be used for Intra oral X-Ray in DentalRadiography for diagnostic purpose

Device Class : 2

Duns Number: 863358955

Premarket Exempt : No

Product Code : EHD

Prescription Use : Yes

Device Count : 1

SKANMOBILE - 08904269403522 Catalog Number :

Device Description : Skanmobile is a high frequency Mobile X-Ray System for diagnostic radiography. T Skanmobile is a high frequency Mobile X-Ray System for diagnostic radiography. The system houses two microprocessors,one for control / supervisory functions and another for man-machine/user interface. The technology incorporatesfeedback circuits to ensure accuracy & reproducibility of X-Ray output.

Device Class : 2

Duns Number: 863358955

Premarket Exempt : No

Product Code : IZL

Prescription Use : Yes

Device Count : 1

SKANMOBILE DR - 08904269403683 Catalog Number :

Device Description : SKANMOBILE DR is a digital radiographic system designed for superior image quali SKANMOBILE DR is a digital radiographic system designed for superior image quality featuring wireless flat panel detectorand operator console for digital imaging integrated with high frequency generator.

Device Class : 2

Duns Number: 863358955

Premarket Exempt : No

Product Code : IZL, MQB

Prescription Use : Yes

Device Count : 1

Skan C Mobile C - Arm X - Ray system - 08904269405519 Catalog Number :

Device Description : SKAN-C, is a mobile X-Ray C-Arm fluoroscopic device to assist in guiding medical SKAN-C, is a mobile X-Ray C-Arm fluoroscopic device to assist in guiding medical intervention surgical procedures. The device can also be used for radiographic applications.

Device Class : 2

Duns Number: 863358955

Premarket Exempt : No

Product Code : OWB, OXO

Prescription Use : Yes

Device Count : 1

SKANRAD 400 - 08904269409531 Catalog Number :

Device Description : Skanrad 400 is an advanced high frequency type X-ray system designed for superio Skanrad 400 is an advanced high frequency type X-ray system designed for superior image quality for radiographic use with powerful 32 kW generator and very low X-ray leakage radiation

Device Class : 2

Duns Number: 863358955

Premarket Exempt : No

Product Code : KPR

Prescription Use : Yes

Device Count : 1

Spotskan - 18904269450301 Catalog Number :

Device Description : Multi-Parameter Spot Check Device

Device Class : 2

Duns Number: 863358955

Premarket Exempt : No

Product Code : MWI, DXN

Prescription Use : Yes

Device Count : 1

SPOTSKAN - 18904269450318 Catalog Number :

Device Description : Multi-Parameter Spot Check Device

Device Class : 2

Duns Number: 863358955

Premarket Exempt : No

Product Code : MWI, DXN

Prescription Use : Yes

Device Count : 1

Star 60 - 18904269450769 Catalog Number :

Device Description : Multipara Patient monitoring system

Device Class : 2

Duns Number: 863358955

Premarket Exempt : No

Product Code : MWI

Prescription Use : Yes

Device Count : 1

Star 60 - 18904269450783 Catalog Number :

Device Description : Multipara Patient monitoring system

Device Class : 2

Duns Number: 863358955

Premarket Exempt : No

Product Code : MWI

Prescription Use : Yes

Device Count : 1

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