Elekta Solutions AB

Elekta Solutions AB

Address:KUNGSTENSGATAN 18,STOCKHOLM,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) (8) Accelerator, Linear, Medical (IYE) (1) System, Planning, Radiation Therapy Treatment (MUJ) (1)

Premarket Exempt

No

Clear

Monaco - 00858164002275 Catalog Number :

Device Class : 2

Duns Number: 353272181

Premarket Exempt : No

Product Code : MUJ

Prescription Use : No

Device Count : 1

Elekta Medical Linear Accelerator - 05060191071505 Catalog Number :

Device Description : Elekta Synergy®

Device Class : 2

Duns Number: 353272181

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

Elekta Medical Linear Accelerator - 05060191071512 Catalog Number :

Device Description : Elekta Infinity™

Device Class : 2

Duns Number: 353272181

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

Elekta Medical Linear Accelerator - 05060191071529 Catalog Number :

Device Description : Versa HD™

Device Class : 2

Duns Number: 353272181

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

Elekta Medical Linear Accelerator - 05060191071543 Catalog Number :

Device Description : Elekta Infinity™

Device Class : 2

Duns Number: 353272181

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

Elekta Medical Linear Accelerator - 05060191071550 Catalog Number :

Device Description : Elekta Synergy®

Device Class : 2

Duns Number: 353272181

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

Elekta Medical Linear Accelerator - 05060191071574 Catalog Number :

Device Description : Versa HD™

Device Class : 2

Duns Number: 353272181

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

Elekta Medical Linear Accelerator - 05060191071581 Catalog Number :

Device Description : Elekta Harmony

Device Class : 2

Duns Number: 353272181

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

Elekta Medical Linear Accelerator - 05060191071604 Catalog Number :

Device Description : Elekta Harmony Pro

Device Class : 2

Duns Number: 353272181

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

MOSAIQ - 07340201500026 Catalog Number :

Device Class : 2

Duns Number: 353272181

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

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