Medical Device Manufacturer · DE , Unterschleissheim

Tomtec Imaging Systems GmbH - FDA 510(k) Cleared Devices

21 submissions · 21 cleared · Since 1999

Recent clearances: TOMTEC-ARENA, TOMTEC-ARENA

Total

Cleared

Denied

Tomtec Imaging Systems GmbH has 21 FDA 510(k) cleared radiology devices. Based in Unterschleissheim, DE.

Last cleared in 2022. 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.

Tomtec Imaging Systems GmbH is one of 234 FDA 510(k) medical device manufacturers from Germany in the dataset, ranked by real submission volume.

FDA 510(k) Regulatory Record - Tomtec Imaging Systems GmbH

21 devices

1-12 of 21

TOMTEC-ARENA 1.0, TOMTEC-ARENA 3D ECHO, CARDIO-ARENA

2D CARDIAC PERFORMANCE ANALYSIS MR 1.0

IMAGE-ARENA AND IMAGE-ARENA APPLICATIONS

IMAGE-ARENA 4.0 AND IA APPLICATIONS 2D CARDIAC PERFORMANCE ANALYSIS 1.0

K090461 · LLZ

Radiology · 88d

Cleared Dec 23, 2008

IMAGE-ARENA APPLICATIONS

K083348 · LLZ

Radiology · 40d

Tomtec Imaging Systems GmbH - FDA 510(k) Cleared Devices

FDA 510(k) Regulatory Record - Tomtec Imaging Systems GmbH

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