510(k) Report

FDA applicant

Dosisoft SA

Cachan, FR8 decisions2011–20260 recalls

FDA records 8 decisions for Dosisoft SA (Cachan, FR) from 2011 to 2026: 8 510(k) clearances. Most are in product codes IYE (Accelerator, Linear, Medical) and LLZ (System, Image Processing, Radiological). Since 2016 its 510(k)s took a median of 182 days from receipt to decision, against 114 for FDA’s reviews in the same codes and years. Its devices cite 8 predicates, 3 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Dosisoft”.

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 Dosisoft SA’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2011: 12012: 12018: 12019: 22024: 12025: 12026 (partial year): 1
2011high 2 (2019) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2011.

FIG. 1 — Dosisoft SA by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Dosisoft SA’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?

  • IYEAccelerator, Linear, Medical4decisions
  • LLZSystem, Image Processing, Radiological2decisions
  • MUJSystem, Planning, Radiation Therapy Treatment2decisions

How long do its 510(k) reviews take?

Since 2016, its 6 510(k)s took a median of 182 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 114 days; 2 of its 6 were faster than that.

Whose devices does it build on?

Its devices cite 8 predicates; 3 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 times; 3 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.

  • K191944MU2netDosisoft · 20191cites it
  • K182966PLANET Onco DoseDosisoft · 20191cites it
  • K112723EpigrayDosisoft SA · 20121cites it
  • K231573ThinkQA (Edition 2)Dosisoft SA · 20241cites it

What has FDA decided for it lately?

  • K252937ThinkQA 3Dosisoft SA · 2026
  • K241765PLANET Onco Dose (3.2)Dosisoft SA · 2025
  • K231573ThinkQA (Edition 2)Dosisoft SA · 2024
  • K191944MU2netDosisoft · 2019
  • K182966PLANET Onco DoseDosisoft · 2019
  • K180106ThinkQADosisoft · 2018
  • K112723EpigrayDosisoft SA · 2012
  • K103146Isogray Treatment Planning SystemDosisoft SA · 2011

All 5 as Dosisoft SA →All 3 as Dosisoft →