Philips Medical Systems (cleveland), Inc.

Address:100 Park Avenue,Orange Village,OH,44122,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, planning, radiation therapy treatment (MUJ) (6) System, x-ray, tomography, computed (JAK) (2) System, tomography, computed, emission (KPS) (1)

Premarket Exempt

Clear

Ingenuity TF - 00884838059443 Catalog Number :

Device Class : 2

Duns Number: 001224989

Premarket Exempt : No

Product Code : JAK, KPS

Prescription Use : Yes

Device Count : 1

Ingenuity Flex - 00884838059528 Catalog Number :

Device Class : 2

Duns Number: 001224989

Premarket Exempt : No

Product Code : JAK

Prescription Use : Yes

Device Count : 1

Philips - 00884838074200 Catalog Number : 459801050601

Device Description : Pinnacle Radiation Therapy Planning System Version 16.0.0.60013

Device Class : 2

Duns Number: 829526560

Premarket Exempt : No

Product Code : MUJ

Prescription Use : Yes

Device Count : 1

Philips - 00884838085602 Catalog Number : 459801050602

Device Description : Pinnacle Radiation Therapy Planning System Version 16.0.1.60003

Device Class : 2

Duns Number: 829526560

Premarket Exempt : No

Product Code : MUJ

Prescription Use : Yes

Device Count : 1

Philips - 00884838091122 Catalog Number : 459801419352

Device Description : Pinnacle3 Radiation therapy treatment planning system version 16.2.1.60098

Device Class : 2

Duns Number: 829526560

Premarket Exempt : No

Product Code : MUJ

Prescription Use : Yes

Device Count : 1

Philips - 00884838098992 Catalog Number : 459801630821

Device Description : Pinnacle Radiation Therapy Planning System Version 16.4.0.60093

Device Class : 2

Duns Number: 829526560

Premarket Exempt : No

Product Code : MUJ

Prescription Use : Yes

Device Count : 1

Pinnacle Radiation Therapy Planning System - 00884838102965 Catalog Number : 45980163082X

Device Class : 2

Duns Number: 829526560

Premarket Exempt : No

Product Code : MUJ

Prescription Use : Yes

Device Count : 1

Pinnacle Radiation Therapy Planning System - 00884838103566 Catalog Number : 45980171803X

Device Class : 2

Duns Number: 118100508

Premarket Exempt : No

Product Code : MUJ

Prescription Use : Yes

Device Count : 1

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