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

System, Imaging, Pulsed Doppler, Ultrasonic (IYN) (9) System, Imaging, Pulsed Echo, Ultrasonic (IYO) (9) Transducer, Ultrasonic, Diagnostic (ITX) (9) Automated Radiological Image Processing Software (QIH) (7) Catheter, Ultrasound, Intravascular (OBJ) (7)

Premarket Exempt

Clear

Affiniti 30 Ultrasound Circular Edition - 00884838113909 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 CVx Ultrasound Circular Edition - 00884838113916 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

EPIQ CVx Ultrasound Circular Edition - 00884838113923 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

Lumify Ultrasound Circular Edition - 00884838113930 Catalog Number :

Device Description : Software version 3.x

Device Class : 2

Duns Number: 063377717

Premarket Exempt : No

Product Code : IYN, ITX, IYO

Prescription Use : Yes

Device Count : 1

Lumify Ultrasound Circular Edition - 00884838113947 Catalog Number :

Device Description : Software version 4.X

Device Class : 2

Duns Number: 063377717

Premarket Exempt : No

Product Code : IYN, ITX, IYO

Prescription Use : Yes

Device Count : 1

EPIQ Elite Ultrasound Circular Edition - 00884838113961 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 70 Diagnostic Ultrasound System - 00884838114456 Catalog Number :

Device Description : Software Version 6.X

Device Class : 2

Duns Number: 063377717

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

Affiniti 70W Diagnostic Ultrasound System - 00884838114463 Catalog Number :

Device Description : Software Version 6.X

Device Class : 2

Duns Number: 063377717

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

Affiniti 70C Diagnostic Ultrasound System - 00884838114470 Catalog Number :

Device Description : Software Version 6.X

Device Class : 2

Duns Number: 063377717

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

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