Ultraspect Usa, LLC

Address:101 Dillion Court,Gray,TN,37615,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

System, Tomography, Computed, Emission (KPS) (10) System, Image Processing, Radiological (LLZ) (8)

Premarket Exempt

Clear

UltraSPECT - 00850040177008 Catalog Number :

Device Description : WBR Imaging X

Device Class : 2

Duns Number: 118594942

Premarket Exempt : No

Product Code : LLZ, KPS

Prescription Use : No

Device Count : 1

UltraSPECT - 00850040177015 Catalog Number :

Device Description : WBR Imaging X3

Device Class : 2

Duns Number: 118594942

Premarket Exempt : No

Product Code : LLZ, KPS

Prescription Use : No

Device Count : 1

UltraSPECT - 00850040177022 Catalog Number :

Device Description : WBR Imaging X + X3

Device Class : 2

Duns Number: 118594942

Premarket Exempt : No

Product Code : LLZ, KPS

Prescription Use : No

Device Count : 1

UltraSPECT - 00850040177039 Catalog Number :

Device Description : WBR Imaging Bone/Xact

Device Class : 2

Duns Number: 118594942

Premarket Exempt : No

Product Code : KPS

Prescription Use : No

Device Count : 1

UltraSPECT - 00850040177046 Catalog Number :

Device Description : WBR Imaging X + Bone/Xact

Device Class : 2

Duns Number: 118594942

Premarket Exempt : No

Product Code : KPS

Prescription Use : No

Device Count : 1

UltraSPECT - 00850040177053 Catalog Number :

Device Description : WBR Imaging X3 + Bone/Xact

Device Class : 2

Duns Number: 118594942

Premarket Exempt : No

Product Code : LLZ, KPS

Prescription Use : No

Device Count : 1

UltraSPECT - 00850040177060 Catalog Number :

Device Description : WBR Imaging X + X3 + Bone/Xact

Device Class : 2

Duns Number: 118594942

Premarket Exempt : No

Product Code : KPS, LLZ

Prescription Use : No

Device Count : 1

UltraSPECT - 00850040177077 Catalog Number :

Device Description : WBR Imaging X + ACSC

Device Class : 2

Duns Number: 118594942

Premarket Exempt : No

Product Code : LLZ, KPS

Prescription Use : No

Device Count : 1

UltraSPECT - 00850040177084 Catalog Number :

Device Description : WBR Imaging X3 + ACSC

Device Class : 2

Duns Number: 118594942

Premarket Exempt : No

Product Code : LLZ, KPS

Prescription Use : No

Device Count : 1

UltraSPECT - 00850040177091 Catalog Number :

Device Description : WBR Imaging X + X3 + ACSC

Device Class : 2

Duns Number: 118594942

Premarket Exempt : No

Product Code : LLZ, KPS

Prescription Use : No

Device Count : 1

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