Philips Ultrasound, Inc.

Address:1 Echo Dr,Reedsville,PA,17084,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

Automated Radiological Image Processing Software (QIH) (10) System, Imaging, Pulsed Doppler, Ultrasonic (IYN) (10) System, Imaging, Pulsed Echo, Ultrasonic (IYO) (10) Transducer, Ultrasonic, Diagnostic (ITX) (10) Catheter, Ultrasound, Intravascular (OBJ) (7)

Premarket Exempt

Clear

CX50 Ultrasound Circular Edition - 00884838113787 Catalog Number :

Device Description : Software version 5.X

Device Class : 2

Duns Number: 063377717

Premarket Exempt : No

Product Code : IYN, ITX, IYO, QIH

Prescription Use : Yes

Device Count : 1

Sparq Ultrasound Circular Edition - 00884838113794 Catalog Number :

Device Description : Software version 2.X

Device Class : 2

Duns Number: 063377717

Premarket Exempt : No

Product Code : IYN, ITX, IYO, QIH

Prescription Use : Yes

Device Count : 1

Sparq Ultrasound Circular Edition - 00884838113800 Catalog Number :

Device Description : Software version 3.X

Device Class : 2

Duns Number: 063377717

Premarket Exempt : No

Product Code : IYN, ITX, IYO, QIH

Prescription Use : Yes

Device Count : 1

EPIQ 7 Ultrasound Circular Edition - 00884838113824 Catalog Number :

Device Description : Software Version 9.X

Device Class : 2

Duns Number: 063377717

Premarket Exempt : No

Product Code : IYN, IYO, ITX, OBJ, QIH

Prescription Use : Yes

Device Count : 1

Affiniti 50 Ultrasound Circular Edition - 00884838113831 Catalog Number :

Device Description : Software Version 7.X

Device Class : 2

Duns Number: 063377717

Premarket Exempt : No

Product Code : IYN, IYO, ITX, OBJ, QIH

Prescription Use : Yes

Device Count : 1

Affiniti 50 Ultrasound Circular Edition - 00884838113848 Catalog Number :

Device Description : 9.X

Device Class : 2

Duns Number: 063377717

Premarket Exempt : No

Product Code : IYN, IYO, ITX, OBJ, QIH

Prescription Use : Yes

Device Count : 1

Affiniti 70 Ultrasound Circular Edition - 00884838113855 Catalog Number :

Device Description : Software version 7.x

Device Class : 2

Duns Number: 063377717

Premarket Exempt : No

Product Code : IYN, IYO, ITX, QIH, OBJ

Prescription Use : Yes

Device Count : 1

Affiniti 70 Ultrasound Circular Edition - 00884838113862 Catalog Number :

Device Description : Software version 9.X

Device Class : 2

Duns Number: 063377717

Premarket Exempt : No

Product Code : IYN, IYO, ITX, OBJ, QIH

Prescription Use : Yes

Device Count : 1

EPIQ 5 Ultrasound Circular Edition - 00884838113886 Catalog Number :

Device Description : Software Version 9.X

Device Class : 2

Duns Number: 063377717

Premarket Exempt : No

Product Code : IYO, IYN, ITX, OBJ, QIH

Prescription Use : Yes

Device Count : 1

Affiniti 30 Ultrasound Circular Edition - 00884838113893 Catalog Number :

Device Description : Software version 7.x

Device Class : 2

Duns Number: 063377717

Premarket Exempt : No

Product Code : IYN, IYO, ITX, QIH, OBJ

Prescription Use : Yes

Device Count : 1

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