ELEKTA LIMITED

Address:FLEMING WAY,CRAWLEY West Sussex,GB

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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) (10)

Premarket Exempt

No Yes

Clear

MLCi2™ - 05060191071024 Catalog Number :

Device Description : MLCi2

Device Class : 2

Duns Number: 525557559

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

Agility™ - 05060191071031 Catalog Number :

Device Description : Agility

Device Class : 2

Duns Number: 525557559

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

XVI - 05060191071048 Catalog Number :

Device Description : XVI

Device Class : 2

Duns Number: 525557559

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

iViewGT™ - 05060191071055 Catalog Number :

Device Description : iViewGT

Device Class : 2

Duns Number: 525557559

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

Integrity™ - 05060191071062 Catalog Number :

Device Description : Integrity

Device Class : 2

Duns Number: 525557559

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

Integrity™ - 05060191071079 Catalog Number :

Device Description : Integrity

Device Class : 2

Duns Number: 525557559

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

Precise Treatment Table™ - 05060191071086 Catalog Number :

Device Description : Precise Treatment Table

Device Class : 2

Duns Number: 525557559

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

XVI - 05060191071093 Catalog Number :

Device Description : XVI Cassette 15x15

Device Class : 2

Duns Number: 525557559

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

XVI - 05060191071109 Catalog Number :

Device Description : XVI Cassette S10

Device Class : 2

Duns Number: 525557559

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

XVI - 05060191071116 Catalog Number :

Device Description : XVI Cassette M15

Device Class : 2

Duns Number: 525557559

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

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