Norland at Swissray

Address:One International Blvd.,Mahwah,NJ,07495,US

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Filters

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

Densitometer, Bone (KGI) (7) System, Imaging, Pulsed Doppler, Ultrasonic (IYN) (3) System, Imaging, Pulsed Echo, Ultrasonic (IYO) (3) Transducer, Ultrasonic, Diagnostic (ITX) (3)

Premarket Exempt

Clear

uREzpocus - 00860008461209 Catalog Number :

Device Description : Ultrasonic pulsed doppler imaging system - Convex HD array

Device Class : 2

Duns Number: 110329096

Premarket Exempt : No

Product Code : IYN, IYO, ITX

Prescription Use : No

Device Count : 1

uREzpocus - 00860008461216 Catalog Number :

Device Description : Ultrasonic pulsed doppler imaging system - uREzpocus H

Device Class : 2

Duns Number: 110329096

Premarket Exempt : No

Product Code : IYN, IYO, ITX

Prescription Use : No

Device Count : 1

uREzpocus - 00860008461223 Catalog Number :

Device Description : Ultrasonic pulsed doppler imaging system - MicroConvex array

Device Class : 2

Duns Number: 110329096

Premarket Exempt : No

Product Code : IYN, IYO, ITX

Prescription Use : No

Device Count : 1

XR-600 Basic - 00866955000409 Catalog Number :

Device Description : XR-600 Basic Bone Densitometer

Device Class : 2

Duns Number: 110329096

Premarket Exempt : No

Product Code : KGI

Prescription Use : Yes

Device Count : 1

XR-600 Clinical - 00866955000416 Catalog Number :

Device Description : XR-600 Clinical Bone Desitometer

Device Class : 2

Duns Number: 110329096

Premarket Exempt : No

Product Code : KGI

Prescription Use : Yes

Device Count : 1

XR-600 Advanced - 00866955000423 Catalog Number :

Device Description : XR-600 Advanced

Device Class : 2

Duns Number: 110329096

Premarket Exempt : No

Product Code : KGI

Prescription Use : Yes

Device Count : 1

XR-800 Basic - 00866955000430 Catalog Number :

Device Description : XR-800 Basic Bone Densitometer

Device Class : 2

Duns Number: 110329096

Premarket Exempt : No

Product Code : KGI

Prescription Use : Yes

Device Count : 1

XR- 800 Clinical - 00866955000447 Catalog Number :

Device Description : XR- 800 Clinical Bone Densitometer

Device Class : 2

Duns Number: 110329096

Premarket Exempt : No

Product Code : KGI

Prescription Use : Yes

Device Count : 1

XR-800 Advanced - 00866955000454 Catalog Number :

Device Description : XR-800 Advanced Bone Densitometer

Device Class : 2

Duns Number: 110329096

Premarket Exempt : No

Product Code : KGI

Prescription Use : Yes

Device Count : 1

Elite - 00866955000461 Catalog Number :

Device Description : Elite Bone Densitometer

Device Class : 2

Duns Number: 110329096

Premarket Exempt : No

Product Code : KGI

Prescription Use : Yes

Device Count : 1

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