510(k) Report

FDA applicant

.Decimal, Inc.

Sanford, FL13 decisions2006–20210 recalls

FDA records 13 decisions for .Decimal, Inc. (Sanford, FL) from 2006 to 2021: 13 510(k) clearances. Most are in product codes MUJ (System, Planning, Radiation Therapy Treatment) and IXI (Block, Beam-Shaping, Radiation Therapy). Since 2016 its 510(k)s took a median of 87 days from receipt to decision, against 56 for FDA’s reviews in the same codes and years. Its devices cite 14 predicates, 6 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “.Decimal, LLC”.

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 .Decimal, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2021

2007: 22009: 22011: 12012: 12013: 12015: 22018: 12019: 12021: 1
2007high 2 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like .Decimal, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • MUJSystem, Planning, Radiation Therapy Treatment7decisions
  • IXIBlock, Beam-Shaping, Radiation Therapy6decisions

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 87 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 56 days; 1 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 14 predicates; 6 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 13 times; 6 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.

  • K071078.Decimal Range Compensator.Decimal, Inc. · 20073cite it
  • K071077.Decimal Aperture.Decimal, Inc. · 20072cite it
  • K151369.decimal p.d.Decimal, LLC · 20152cite it
  • K091911Bolus Compensator.Decimal, Inc. · 20092cite it
  • K111759.Decimal Electron Aperture.Decimal, Inc. · 20111cites it
  • K083672P.D Software.Decimal, Inc. · 20091cites it

What has FDA decided for it lately?

  • K211511decimal Bolus.Decimal, LLC · 2021
  • K192554decimal3D.Decimal, LLC · 2019
  • K173940Astroid Planning App.Decimal, LLC · 2018
  • K151369.decimal p.d.Decimal, LLC · 2015
  • K150547.decimal Astroid Dosimetry App.Decimal, Inc. · 2015
  • K132236.Decimal Proton Aperture.Decimal, Inc. · 2013
  • K123015.Decimal Photon Block.Decimal, Inc. · 2012
  • K111759.Decimal Electron Aperture.Decimal, Inc. · 2011

All 9 as .Decimal, Inc. →All 4 as .Decimal, LLC →