# Confirma, Inc.

- Location (FDA's records): Kirkland, WA
- FDA decisions: 9 (2002–2009): 9 510(k) clearances
- Product codes: LLZ (5), MOS (3), LNH (1)
- Predicates its devices cite: 30 (4 its own); citations of its devices by later devices: 17 (4 its own)
- Recalls linked to its devices: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Mri Devices Corp.: 4 (https://510kreport.com/company/mri-devices)
- Machnet BV: 3 (https://510kreport.com/company/machnet)
- Sectra-Imtec AB: 2 (https://510kreport.com/company/sectra-imtec)
- 3tp, LLC: 2 (https://510kreport.com/company/3tp)
- Ge Medical Systems W-400: 1 (https://510kreport.com/company/ge-medical-systems-w-400)
- Cedara Software Corp.: 1 (https://510kreport.com/company/cedara-software)
- Medtronic Navigation, Inc.: 1 (https://510kreport.com/company/medtronic-navigation)
- Usa Instruments, Inc.: 1 (https://510kreport.com/company/usa-instruments)

## Firms that cite its devices most
- Siemens Medical Solutions USA, Inc.: 2 (https://510kreport.com/company/siemens-medical-solutions-usa)
- Mri Devices Corp.: 2 (https://510kreport.com/company/mri-devices)
- Quantitative Insights, Inc.: 2 (https://510kreport.com/company/quantitative-insights)
- Sentinelle Medical, Inc.: 1 (https://510kreport.com/company/sentinelle-medical)
- Dde Mri Solutions, Ltd.: 1 (https://510kreport.com/company/dde-mri-solutions)
- The Medipattern Corporation: 1 (https://510kreport.com/company/medipattern)
- Clario Medical Imaging, Inc.: 1 (https://510kreport.com/company/clario-medical-imaging)
- SimBioSys, Inc.: 1 (https://510kreport.com/company/simbiosys)

## Its most-cited devices
- K043216: Cadstream Version 4.0 (2005), cited by 9
- K031779: Cadstream (2003), cited by 3
- K092954: Cadstream Version 5 (2009), cited by 2
- K081556: Cadstream, Version 5.0 (2009), cited by 2
- K013574: Accent (2002), cited by 1

## Recent decisions
- K092954: Cadstream Version 5 (Nov 6, 2009)
- K081556: Cadstream, Version 5.0 (Feb 2, 2009)
- K071534: Confirma Breast Mri Interventional Components (Jul 9, 2007)
- K060547: Access Breast Coil 4/SMS (Mar 29, 2006)
- K052045: Access Breast Coil (Aug 24, 2005)
- K043216: Cadstream Version 4.0 (Jan 6, 2005)
- K041020: Cadstream Version 3.1 (Jul 7, 2004)
- K031779: Cadstream (Aug 6, 2003)

Source page: https://510kreport.com/company/confirma