Aktina Corp.

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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) (7) Couch, Radiation Therapy, Powered (JAI) (3)

Premarket Exempt

No Yes

Clear

Oblique Treatment Panel with Inserts - B365112020 Catalog Number :

Device Class : 2

Duns Number: 787178920

Premarket Exempt : No

Product Code : IYE

Prescription Use : No

Device Count : 1

Metal Frame Table Insert, Elekta Precise - B365112050 Catalog Number :

Device Class : 2

Duns Number: 787178920

Premarket Exempt : No

Product Code : JAI

Prescription Use : No

Device Count : 1

Carbon Fiber Table Insert - B365112060 Catalog Number :

Device Class : 2

Duns Number: 787178920

Premarket Exempt : No

Product Code : IYE

Prescription Use : No

Device Count : 1

C-Arm Solid Panel Insert - B365112110 Catalog Number :

Device Class : 2

Duns Number: 787178920

Premarket Exempt : No

Product Code : IYE

Prescription Use : No

Device Count : 1

Extension Board for Aktina IGRT Table Top - B365112120 Catalog Number :

Device Class : 2

Duns Number: 787178920

Premarket Exempt : No

Product Code : IYE

Prescription Use : No

Device Count : 1

Indexed IGRT Table Top - B365112130 Catalog Number :

Device Description : High-Modulus carbon-fiber indexed treatment / imaging system

Device Class : 2

Duns Number: 787178920

Premarket Exempt : No

Product Code : IYE

Prescription Use : No

Device Count : 1

Host Board Assembly for Aktina IGRT Table Top - B365112140 Catalog Number :

Device Class : 2

Duns Number: 787178920

Premarket Exempt : No

Product Code : IYE

Prescription Use : No

Device Count : 1

Standard Panel for Aktina IGRT Table Top - B365112150 Catalog Number :

Device Class : 2

Duns Number: 787178920

Premarket Exempt : No

Product Code : IYE

Prescription Use : No

Device Count : 1

Carbon Fiber Mesh Table Insert, Central Openings - B365112160 Catalog Number :

Device Class : 2

Duns Number: 787178920

Premarket Exempt : No

Product Code : JAI

Prescription Use : No

Device Count : 1

Solid Carbon Fiber Table Insert, Central Opening - B36511216S0 Catalog Number :

Device Class : 2

Duns Number: 787178920

Premarket Exempt : No

Product Code : JAI

Prescription Use : No

Device Count : 1

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