Medical Device Manufacturer · FI , Helsinki

Soredex Palodex Group OY - FDA 510(k) Cleared Devices

9 submissions · 9 cleared · Since 2001

Recent clearances: SCANORA 3D, SCANORA 3D, DIGORA PCT/DIGIPOD

View 9 510(k) Devices ↓

9

Total

9

Cleared

0

Denied

FDA 510(k) Regulatory Record - Soredex Palodex Group OY Radiology ✕

9 devices

1-9 of 9

Cleared Jun 30, 2011

Radiology · 97d

Cleared Dec 19, 2007

Radiology · 20d

Cleared Mar 27, 2007

DIGORA PCT/DIGIPOD

Radiology · 55d

Cleared Dec 26, 2006

Radiology · 41d

Cleared Dec 17, 2004

Radiology · 16d

Cleared Jul 13, 2004

CRANEX BASEX D OR CRANEX EXCEL D

Radiology · 147d

Cleared Jun 15, 2004

DIGORA OPTIME (OR DIGORA ONTIME)

Radiology · 54d

Cleared Apr 29, 2004

Radiology · 150d

Cleared Aug 10, 2001

Radiology · 29d

Data Source

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

Last updated: Sep 15, 2026