Medical Device Manufacturer · US , Deer Field , IL

Sedecal., Sa. - FDA 510(k) Cleared Devices

26 submissions · 26 cleared · Since 2002

Recent clearances: SM-IV, SM-V, PHOENIX/AeroDR TX m01 and PHOENIX/mKDR Xpress.

Total

Cleared

Denied

Sedecal., Sa. has 26 FDA 510(k) cleared radiology devices. Based in Deer Field, US.

Last cleared in 2023. Active since 2002.

Browse the complete list of FDA 510(k) cleared radiology devices from this manufacturer. Filter by specialty or product code using the sidebar.

Regulatory submissions have been managed by Kamm & Associates and Laura Green, LLC.

Sedecal., Sa. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.

FDA 510(k) Regulatory Record - Sedecal., Sa.

26 devices

1-12 of 26

PHOENIX/AeroDR TX m01 and PHOENIX/mKDR Xpress.

Proteus XR/f, Models ST and ET, Multirad and Multirad NET Radiographic Systems

K203537 · KPR

Radiology · 60d

Cleared Oct 07, 2020

Radiographic System Challenge X

MobileDiagnost wDR 2.2

K191813 · IZL

Radiology · 28d

Cleared Jan 26, 2018

DRAGON X SPSL4HC, DRAGON X SPSL8HC

Data Source

Sourced from the FDA 510(k) public files . 175,218 total devices indexed.

Last updated: Apr 27, 2026

Sedecal., Sa. - FDA 510(k) Cleared Devices

FDA 510(k) Regulatory Record - Sedecal., Sa.

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