Medical Device Manufacturer · SE , Linkoping

Syntheticmr AB - FDA 510(k) Cleared Devices

6 submissions · 6 cleared · Since 2017

6

Total

6

Cleared

0

Denied

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

6 devices

1-6 of 6

Cleared Nov 03, 2021

Radiology · 352d

Cleared Jul 28, 2020

Radiology · 43d

Cleared Jun 13, 2019

Radiology · 56d

Cleared Jun 12, 2018

Radiology · 48d

Cleared Jan 26, 2018

Radiology · 70d

Cleared Aug 29, 2017

Radiology · 312d

Data Source

Sourced from the FDA 510(k) public files . 174,883 total devices indexed.

Last updated: May 22, 2026