SIEMENS MEDICAL SOLUTIONS USA, INC.

SIEMENS MEDICAL SOLUTIONS USA, INC.

Address:810 INNOVATION DR.,KNOXVILLE,TN,37932,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

Catheter, ultrasound, intravascular (OBJ) (5) System, tomography, computed, emission (KPS) (3) System, image processing, radiological (LLZ) (2)

Premarket Exempt

No Yes

Clear

AcuNav 10F Ultrasound Catheter - 04056869001012 Catalog Number :

Device Class : 2

Duns Number: 804722783

Premarket Exempt : No

Product Code : OBJ

Prescription Use : No

Device Count : 1

AcuNav 8F Ultrasound Catheter - 04056869001029 Catalog Number :

Device Class : 2

Duns Number: 804722783

Premarket Exempt : No

Product Code : OBJ

Prescription Use : No

Device Count : 1

AcuNav G 10F Ultrasound Catheter - 04056869001036 Catalog Number :

Device Class : 2

Duns Number: 804722783

Premarket Exempt : No

Product Code : OBJ

Prescription Use : No

Device Count : 1

AcuNav G 8F Ultrasound Catheter - 04056869001043 Catalog Number :

Device Class : 2

Duns Number: 804722783

Premarket Exempt : No

Product Code : OBJ

Prescription Use : No

Device Count : 1

AcuNav V 10F Ultrasound Catheter - 04056869001050 Catalog Number :

Device Class : 2

Duns Number: 804722783

Premarket Exempt : No

Product Code : OBJ

Prescription Use : No

Device Count : 1

sUSBA Software, VA25A - 04056869001067 Catalog Number :

Device Class : 2

Duns Number: 804722783

Premarket Exempt : No

Product Code : LLZ

Prescription Use : No

Device Count : 1

sUSBA SW, VA20B - 04056869001074 Catalog Number :

Device Class : 2

Duns Number: 804722783

Premarket Exempt : No

Product Code : LLZ

Prescription Use : No

Device Count : 1

Symbia E Dual Head System - 04056869001159 Catalog Number :

Device Class : 2

Duns Number: 868230876

Premarket Exempt : No

Product Code : KPS

Prescription Use : No

Device Count : 1

Symbia S Series - 04056869001166 Catalog Number :

Device Class : 2

Duns Number: 868230876

Premarket Exempt : No

Product Code : KPS

Prescription Use : No

Device Count : 1

Symbia_T - 04056869001173 Catalog Number :

Device Class : 2

Duns Number: 868230876

Premarket Exempt : No

Product Code : KPS

Prescription Use : No

Device Count : 1

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