510(k) Report

FDA applicant

C-Rad Positioning AB

Uppsala, SE6 decisions2007–20203 recalls

FDA records 6 decisions for C-Rad Positioning AB (Uppsala, SE) from 2007 to 2020: 6 510(k) clearances. All are in product code IYE (Accelerator, Linear, Medical). Its devices cite 7 predicates, 4 of them its own earlier devices. 3 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 C-Rad Positioning AB’s devices, and how often a recall has named them.

FDA decisions per year

2in 2020

2007: 12009: 12012: 22020: 2
2007high 2 (2012) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

2in 2025

2020: 12025: 2
2007high 2 (2025) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — C-Rad Positioning AB 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?

  • IYEAccelerator, Linear, Medical6decisions

Whose devices does it build on?

Its devices cite 7 predicates; 4 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 5 times; 4 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.

  • K113276CatalystC-Rad Positioning AB · 20122cite it
  • K082582Sentinel, Model SP-001C-Rad Positioning AB · 20092cite it
  • K120668SentinelC-Rad Positioning AB · 20121cites it

What has FDA decided for it lately?

  • K200435Catalyst+, Catalyst+ HDC-Rad Positioning AB · 20202 recalls
  • K200600SentinelC-Rad Positioning AB · 2020
  • K120668SentinelC-Rad Positioning AB · 2012
  • K113276CatalystC-Rad Positioning AB · 20121 recall
  • K082582Sentinel, Model SP-001C-Rad Positioning AB · 2009
  • K063839PositionerC-Rad Positioning AB · 2007

All 6 as C-Rad Positioning AB →

What has been recalled?

3 recalls linked to its devices; the latest:

  • K200435Brand Name: Catalyst+ Product Name: Catalyst, Catalyst+ Model/Catalog Number…Oct 9, 2025Class II
  • K200435Brand Name: Catalyst+ Product Name: C4D software used in conjunction with Catalyst…Apr 22, 2025Class II
  • K113276PC Application Software c4D as part of the device Catalyst: SP-002 Software PA-003…Aug 6, 2020Class II