Medical Device Manufacturer · SE , Vaxjo

Arcoma AB - FDA 510(k) Cleared Devices

2 submissions · 2 cleared · Since 2008

Recent clearances: 0180 INTUITION, 0072 PRECISION, INTUITION, MODEL 0170

View 2 510(k) Devices ↓

2

Total

2

Cleared

0

Denied

FDA 510(k) Regulatory Record - Arcoma AB Radiology ✕

2 devices

1-2 of 2

Cleared Jun 03, 2014

0180 INTUITION, 0072 PRECISION

Radiology · 77d

Cleared Jan 10, 2008

INTUITION, MODEL 0170

Radiology · 15d

Data Source

Sourced from the FDA 510(k) public files . 176,325 total devices indexed.

Last updated: Sep 20, 2026