Efficast 35774/2MA/G17

• FDA 510(k) K991319 decided 21 Sep 1999 Active
• FDA GUDID UDI-DI 05420028746561 listed 15 Apr 2026 Listed

1. 21 Sep 1999 Cleared FDA 510(k) K991319
2. 15 Apr 2026 Listed FDA GUDID 05420028746561

Trade name

Efficast

Generic name

Radiological whole-body positioner

Model / reference

35774/2MA/G17

Primary DI / UDI-DI

05420028746561

510(k) Number

K991319 ↗

FDA product code

IYE

GMDN term

Radiological whole-body positioner

Device class

Class II

Regulation number

892.5050

GUDID distribution status

In Commercial Distribution

MRI safety

MR Safe

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See all devices from Orfit Industries NV →