Manufacturer

Aktina

United StatesLegal entities : Aktina Medical Corp

Markets : Austria · United States

Approvals : EU – class I, IIa, IIb · United States (FDA) – 510(k) : 4 · class I, II · latest in 2019 · see on the FDA website

EU representative : European Healthcare & Device Solutions Ltd. (Ireland)

2 categories, 28 models including 28 on the market, 1 country

Category	EMDN code	Registered models	Class	Contact
Linear accelerators - other	Z11010199	AK550 Table Top3 refs AKTINA BREATHING COORDINATOR 12-20093/42 AKTINA BREATHING COORDINATOR CONTROL MODULE93/42 Arm Cradle2 refs Beam Block Elekta3 refs 22 others Beam Block Siemens3 refs Body Cradle2 refs Breast Board3 refs Cassette Holder3 refs CT Overlay3 refs Front Pointer Elekta Open Air Graticule3 refs PinPoint Accessory3 refs PInPoint System3 refs Port Film Graticule Elekta2 refs Port Film Graticule Siemens2 refs PositionPro Component3 refs Prone Breast Board Respiratory Compression Belt3 refs Reticle Siemens3 refs Siemens Wedge3 refs Small Field Collimator, Elekta Circular Small Field Collimators Elekta Integrated3 refs Table Top Accessory Elekta6 refs Table Top Accessory Siemens3 refs Thermoplastic Mask3 refs Wedge Filter Elekta3 refs Winston-Lutz Marker	I, IIa, IIb MDR, 93/42	EUDAMED record Report an error
Linear accelerators - consumables	Z11010185	Mouthpiece and Filter ABC3 refs	IIa MDR	EUDAMED record Report an error

A model registered in EUDAMED is not necessarily sold in your country. Check availability and CE marking with the manufacturer.

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