510(k) Report

FDA applicant

Confirma, Inc.

Kirkland, WA9 decisions2002–20093 recalls

FDA records 9 decisions for Confirma, Inc. (Kirkland, WA) from 2002 to 2009: 9 510(k) clearances. Most are in product codes LLZ (System, Image Processing, Radiological) and MOS (Coil, Magnetic Resonance, Specialty). Its devices cite 30 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 Confirma, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2009

2007: 12009: 2
2007high 2 (2009) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

1in 2016

2011: 12012: 12016: 1
2007high 1 (2011) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Confirma, 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?

  • LLZSystem, Image Processing, Radiological5decisions
  • MOSCoil, Magnetic Resonance, Specialty3decisions
  • LNHSystem, Nuclear Magnetic Resonance Imaging1decision

Whose devices does it build on?

Its devices cite 30 predicates; 4 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 17 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.

  • K043216Cadstream Version 4.0Confirma, Inc. · 20059cite it
  • K031779CadstreamConfirma, Inc. · 20033cite it
  • K092954Cadstream Version 5Confirma, Inc. · 20092cite it
  • K081556Cadstream, Version 5.0Confirma, Inc. · 20092cite it
  • K013574AccentConfirma, Inc. · 20021cites it

What has FDA decided for it lately?

  • K092954Cadstream Version 5Confirma, Inc. · 20093 recalls
  • K081556Cadstream, Version 5.0Confirma, Inc. · 2009
  • K071534Confirma Breast Mri Interventional ComponentsConfirma, Inc. · 2007
  • K060547Access Breast Coil 4/SMSConfirma, Inc. · 2006
  • K052045Access Breast CoilConfirma, Inc. · 2005
  • K043216Cadstream Version 4.0Confirma, Inc. · 2005
  • K041020Cadstream Version 3.1Confirma, Inc. · 2004
  • K031779CadstreamConfirma, Inc. · 2003

All 9 as Confirma, Inc. →

What has been recalled?

3 recalls linked to its devices; the latest:

  • K092954CADstream software. The firm name on the label is Merge Healthcare, Hartland, WI.Jan 30, 2016Class II
  • K092954CADstream software. Product Usage: CADstream is an image processing system designed to…Nov 1, 2012Class II
  • K092954CADstream software Product Usage: CADstream is an image processing system designed to…Oct 19, 2011Class II