Medical Device Manufacturer · NL , Leiden

Medis Medical Imaging Systems BV - FDA 510(k) Cleared Devices

18 submissions · 18 cleared · Since 1999

Recent clearances: QGuideCT (1.0), Qangio XA 3D, MR-CT VVA

View 18 510(k) Devices ↓

Total

Cleared

Denied

Medis Medical Imaging Systems BV has 18 FDA 510(k) cleared radiology devices. Based in Leiden, NL.

Latest FDA clearance: Oct 2026. Active since 1999.

Browse the complete list of FDA 510(k) cleared radiology devices from this manufacturer. Filter by specialty or product code using the sidebar.

Medis Medical Imaging Systems BV is one of 150 FDA 510(k) medical device manufacturers from Netherlands in the dataset, ranked by real submission volume.

FDA 510(k) Regulatory Record - Medis Medical Imaging Systems BV

18 devices

1-12 of 18

QUANTITATIVE VASCULAR ANGIOGRAPHY - CMS

K023970 · IZI

Radiology · 56d

Medis Medical Imaging Systems BV - FDA 510(k) Cleared Devices

FDA 510(k) Regulatory Record - Medis Medical Imaging Systems BV

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