510(k) Report

FDA applicant

Orion Corporation Soredex

Helsinki, FI4 decisions1988–19981 recall

FDA records 4 decisions for Orion Corporation Soredex (Helsinki, FI) from 1988 to 1998: 4 510(k) clearances. Most are in product codes EHD (Unit, X-Ray, Extraoral With Timer) and MUH (System, X-Ray, Extraoral Source, Digital). Its devices cite 3 predicates, 1 of them its own earlier devices. 1 recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, dental panel, where it files most

How often FDA has decided Orion Corporation Soredex’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Orion Corporation Soredex since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Orion Corporation Soredex by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • EHDUnit, X-Ray, Extraoral With Timer1decision
  • MUHSystem, X-Ray, Extraoral Source, Digital1decision
  • KPRSystem, X-Ray, Stationary1decision
  • IXKSystem, Imaging, X-Ray, Electrostatic1decision

Whose devices does it build on?

Its devices cite 3 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 7 times; 1 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K934949DigoraOrion Corporation Soredex · 19945cite it
  • K983267Digora for Windows 2.0Orion Corporation Soredex · 19981cites it
  • K880982Oralix Pan DC Iii Ceph or Panoramic Mode OnlyOrion Corporation Soredex · 19881cites it

What has FDA decided for it lately?

  • K983267Digora for Windows 2.0Orion Corporation Soredex · 1998
  • K974877Cranex Tome Ceph, or Cranex TomeOrion Corporation Soredex · 19981 recall
  • K934949DigoraOrion Corporation Soredex · 1994
  • K880982Oralix Pan DC Iii Ceph or Panoramic Mode OnlyOrion Corporation Soredex · 1988

All 4 as Orion Corporation Soredex →

What has been recalled?

1 recall linked to its devices; the latest:

  • K974877Cranex Tome panoramic x-ray unit with Spiral Tomography for cross-sectional imaging.…Apr 28, 2006

Other applicant names beginning “Orion”

FDA records each applicant name separately; these may or may not be the same firm.

Orion Life Systems, Inc. 33Orion Diagnostica, Inc. 32Orion Corp. 21Orion Diagnostica, Div. Orion Corp. 4Orion Industries 1Orion Biotech, Inc. 1