Scandidos AB

Address:UPPSALA SCIENCE PARK 52A,UPPSALA,SE

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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

Accelerator, Linear, Medical (IYE) (9) Instrument, Quality-Assurance, Radiologic (LHO) (1)

Premarket Exempt

No Yes

Clear

Delta4 Phantom+ - 17350005180000 Catalog Number : SDOS101-20

Device Description : The intended use of the device is• quality assurance of patient specific treatme

Device Class : 2

Duns Number: 507639297

Premarket Exempt : No

Product Code : IYE

Prescription Use : No

Device Count : 1

Delta4 Phantom+ - 17350005180017 Catalog Number : SDOS101-21

Device Description : The intended use of the device is• quality assurance of patient specific treatme

Device Class : 2

Duns Number: 507639297

Premarket Exempt : No

Product Code : IYE

Prescription Use : No

Device Count : 1

Delta4 Phantom+ - 17350005180024 Catalog Number : SDOS101-35

Device Description : The intended use of the device is• quality assurance of patient specific treatme

Device Class : 2

Duns Number: 507639297

Premarket Exempt : No

Product Code : IYE

Prescription Use : No

Device Count : 1

Delta4 Phantom+ - 17350005180031 Catalog Number : SDOS101-30

Device Description : The intended use of the device is• quality assurance of patient specific treatme

Device Class : 2

Duns Number: 507639297

Premarket Exempt : No

Product Code : IYE

Prescription Use : No

Device Count : 1

Delta4 Phantom+ MR - 17350005180048 Catalog Number : SDOS101-36

Device Description : The intended use of the device is• quality assurance of patient specific treatme

Device Class : 2

Duns Number: 507639297

Premarket Exempt : No

Product Code : IYE

Prescription Use : No

Device Count : 1

HexaMotion - 17350005180055 Catalog Number : SDOS104-05

Device Description : The intended use of the device is to realize a multi-dimensional movement patter

Device Class : 1

Duns Number: 507639297

Premarket Exempt : Yes

Product Code : LHO

Prescription Use : No

Device Count : 1

Delta4 Discover - 17350005180062 Catalog Number : SDOS105-01 (Varian)

Device Description : The intended use of the device is• quality assurance of patient specific treatme

Device Class : 2

Duns Number: 507639297

Premarket Exempt : No

Product Code : IYE

Prescription Use : No

Device Count : 1

Delta4 Discover - 17350005180079 Catalog Number : SDOS105-02

Device Description : The intended use of the device is• quality assurance of patient specific treatme

Device Class : 2

Duns Number: 507639297

Premarket Exempt : No

Product Code : IYE

Prescription Use : No

Device Count : 1

Delta4 Phantom+ MR - 17350005180086 Catalog Number : SDOS101-34

Device Description : The intended use of the device is• quality assurance of patient specific treatme

Device Class : 2

Duns Number: 507639297

Premarket Exempt : No

Product Code : IYE

Prescription Use : No

Device Count : 1

Delta4 Phantom+ - 17350005180093 Catalog Number : SDOS101-46

Device Description : The intended use of the device is• quality assurance of patient specific treatme

Device Class : 2

Duns Number: 507639297

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

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