Medical Device Manufacturer · BE , Wijnegem

Orfit Industries NV - FDA 510(k) Cleared Devices

9 submissions · 9 cleared · Since 2013

Recent clearances: The AIO Solution 3.0, Orfit Aerial Couchtop, The AIO Solution

Total

Cleared

Denied

Orfit Industries NV has 9 FDA 510(k) cleared medical devices. Based in Wijnegem, BE.

Historical record: 9 cleared submissions from 2013 to 2020. Primary specialty: Radiology.

Browse the FDA 510(k) cleared devices submitted by Orfit Industries NV Filter by specialty or product code using the sidebar.

Regulatory submissions have been managed by Arazy Group Consultants, Inc., P/L Biomedical and Third Party Review Group, LLC.

Orfit Industries NV is one of 40 FDA 510(k) medical device manufacturers from Belgium in the dataset, ranked by real submission volume.

FDA 510(k) Regulatory Record - Orfit Industries NV

9 devices

1-9 of 9

Orfit Aerial Couchtop

HP PRO Positioning Device

K171734 · IYE

Radiology · 43d

Cleared Nov 22, 2016

Raycast MammoRx Carbon Fibre Breast Board

K162355 · IYE

Radiology · 91d

Cleared Nov 09, 2016

Raycast High Precision Lung Board Solution

K162862 · IYE

Radiology · 28d

Cleared Jul 28, 2015

Proton Immobilization Solution

NANOR AND EFFICAST/NANOR HYBRID THERMOPLASTIC MATERIALS

K131795 · IYE

Radiology · 100d

Data Source

Sourced from the FDA 510(k) public files . 175,972 total devices indexed.

Last updated: May 28, 2026

Orfit Industries NV - FDA 510(k) Cleared Devices

FDA 510(k) Regulatory Record - Orfit Industries NV

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