Medical Device Manufacturer · SE , Stockholm

Raysearch Laboratories AB - FDA 510(k) Cleared Devices

7 submissions · 7 cleared · Since 2008

Recent clearances: RAYSTATION, RAY STATION, RAYSTATION

View 7 510(k) Devices ↓

7

Total

7

Cleared

0

Denied

FDA 510(k) Regulatory Record - Raysearch Laboratories AB Radiology ✕

7 devices

1-7 of 7

Cleared Oct 23, 2014

Radiology · 105d

Cleared May 15, 2014

Radiology · 111d

Cleared May 10, 2013

Radiology · 64d

Cleared Apr 06, 2012

Radiology · 59d

Cleared Mar 12, 2010

RAYSTATION VERSION 1.0

Radiology · 14d

Cleared Jan 22, 2009

RAYAUTOPLAN 1.0

Radiology · 78d

Cleared Oct 22, 2008

Radiology · 77d

Data Source

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

Last updated: Sep 17, 2026