The AIO Solution 32015/8

• FDA 510(k) K191158 decided 6 Aug 2019 Active
• FDA GUDID UDI-DI 05401172011439 listed 15 Apr 2026 Listed

1. 6 Aug 2019 Cleared FDA 510(k) K191158
2. 15 Apr 2026 Listed FDA GUDID 05401172011439

Trade name

The AIO Solution

Generic name

Radiological whole-body positioner

Model / reference

32015/8

Primary DI / UDI-DI

05401172011439

510(k) Number

K191158 ↗

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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• Orfit 32108

  Class II

  FDA 510(k) K991319 Active Cleared 21 Sep 1999 GUDID on market

• The AIO Solution 32015/9

  Class II

  FDA 510(k) K191158 Active Cleared 6 Aug 2019 GUDID on market

• The AIO Solution 32015/9/1

  Class II

  FDA 510(k) K191158 Active Cleared 6 Aug 2019 GUDID on market

• The AIO Solution 32015/9/2

  Class II

  FDA 510(k) K191158 Active Cleared 6 Aug 2019 GUDID on market

See all devices from Orfit Industries NV →