510(k) Report

FDA applicant

Palodex Group OY

Tuusula, FI10 decisions2012–20242 recalls

FDA records 10 decisions for Palodex Group OY (Tuusula, FI) from 2012 to 2024: 10 510(k) clearances. Most are in product codes OAS (X-Ray, Tomography, Computed, Dental) and MUH (System, X-Ray, Extraoral Source, Digital). Since 2016 its 510(k)s took a median of 105 days from receipt to decision, against 107 for FDA’s reviews in the same codes and years. Its devices cite 15 predicates, 7 of them its own earlier devices. 2 recalls are linked to its devices.

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

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

How often FDA has decided Palodex Group OY’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2012: 12013: 12014: 12017: 42018: 12023: 12024: 1
2012high 4 (2017) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

1in 2021

2018: 12021: 1
2012high 1 (2018) · low 0 (2012)2026

Class I Class II/III not classified

FIG. 1 — Palodex Group OY by year, 2012–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • OASX-Ray, Tomography, Computed, Dental8decisions
  • MUHSystem, X-Ray, Extraoral Source, Digital1decision
  • LLZSystem, Image Processing, Radiological1decision

How long do its 510(k) reviews take?

Since 2016, its 7 510(k)s took a median of 105 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 107 days; 2 of its 7 were faster than that.

Whose devices does it build on?

Its devices cite 15 predicates; 7 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 11 times; 7 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.

  • K133544OP300Palodex Group OY · 20144cite it
  • K162799CliniviewPalodex Group OY · 20173cite it
  • K122018OP300Palodex Group OY · 20121cites it
  • K180947Orthopantomograph OP 3DPalodex Group OY · 20181cites it
  • K230505Orthopantomograph™ OP 3D LXPalodex Group OY · 20231cites it
  • K163423Orthopantomograph OP300Palodex Group OY · 20171cites it

What has FDA decided for it lately?

  • K241249Orthopantomograph™ OP 3D LX (PAN 3D); Orthopantomograph™ OP 3D LX (PAN CEPH 3D)Palodex Group OY · 2024
  • K230505Orthopantomograph™ OP 3D LXPalodex Group OY · 2023
  • K180947Orthopantomograph OP 3DPalodex Group OY · 20181 recall
  • K173646FS ErgoPalodex Group OY · 2017
  • K163423Orthopantomograph OP300Palodex Group OY · 20171 recall
  • K162799CliniviewPalodex Group OY · 2017
  • K170813Orthopantomograph OP 3DPalodex Group OY · 20171 recall
  • K133544OP300Palodex Group OY · 2014

All 10 as Palodex Group OY →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K163423Orthopantomograph OP300 dental computed tomography x-ray system. The X-ray device…Oct 28, 2021Class II
  • K180947cone-beam CT systemDec 31, 2018Class II