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) (9) Table, radiologic (KXJ) (1)

Premarket Exempt

No Yes

Clear

Active Breathing Coordinator - 05060191071277 Catalog Number :

Device Description : Active Breathing Coordinator

Device Class : 2

Duns Number: 525557559

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

Active Breathing Coordinator - 05060191071284 Catalog Number :

Device Description : Control Module, Active Breathing Coordinator

Device Class : 2

Duns Number: 525557559

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

Elekta Unity - 05060191071321 Catalog Number :

Device Description : Elekta Unity

Device Class : 2

Duns Number: 525557559

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

Integrity™ - 05060191071345 Catalog Number :

Device Description : Integrity

Device Class : 2

Duns Number: 525557559

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

Elekta Unity - 05060191071420 Catalog Number :

Device Description : INDEXING BAR

Device Class : 2

Duns Number: 525557559

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

Elekta Unity - 05060191071437 Catalog Number :

Device Description : INDEXING BARS

Device Class : 2

Duns Number: 525557559

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

Elekta Unity - 05060191071468 Catalog Number :

Device Description : CT OVERLAY

Device Class : 2

Duns Number: 525557559

Premarket Exempt : Yes

Product Code : KXJ

Prescription Use : Yes

Device Count : 1

Elekta Unity - 05060191071482 Catalog Number :

Device Description : Indexing Bar

Device Class : 2

Duns Number: 525557559

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

Elekta Unity - 05060191071499 Catalog Number :

Device Description : Indexing Bars

Device Class : 2

Duns Number: 525557559

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

Elekta Unity - 05060191071598 Catalog Number :

Device Description : Elekta Unity

Device Class : 2

Duns Number: 525557559

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

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