# Vital Images, Inc.

- Location (FDA's records): Minnetonka, MN
- FDA decisions: 41 (1995–2018): 41 510(k) clearances
- Product codes: LLZ (34), JAK (7)
- 510(k) review time since 2016: median 53 days, against 106 for FDA's reviews in the same codes and years (5 of 8 faster)
- Predicates its devices cite: 66 (35 its own); citations of its devices by later devices: 95 (35 its own)
- Recalls linked to its devices: 10 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- R2 Technology, Inc.: 4 (https://510kreport.com/company/r2-technology)
- Toshiba America Medical Systems, In.C: 3 (https://510kreport.com/company/toshiba-america-medical-systems-in-c)
- Mirada Solutions, Ltd.: 3 (https://510kreport.com/company/mirada-solutions)
- Toshibamedical Systems Corporation: 3 (https://510kreport.com/company/toshibamedical-systems)
- GE Medical Systems: 3 (https://510kreport.com/company/ge-medical-systems)
- Medical Media Systems: 1 (https://510kreport.com/company/medical-media-systems)
- GE Healthcare: 1 (https://510kreport.com/company/ge-healthcare)
- General Electric Co.: 1 (https://510kreport.com/company/general-electric)

## Firms that cite its devices most
- Viatronix, Inc.: 6 (https://510kreport.com/company/viatronix)
- Calgary Scientific, Inc.: 4 (https://510kreport.com/company/calgary-scientific)
- Canon Medical Informatics, Inc.: 3 (https://510kreport.com/company/canon-medical-informatics)
- Intrasense: 3 (https://510kreport.com/company/intrasense)
- Medis Medical Imaging Systems BV: 2 (https://510kreport.com/company/medis-medical-imaging-systems)
- MeVis Medical Solutions AG: 2 (https://510kreport.com/company/mevis-medical-solutions)
- Paieon, Inc.: 2 (https://510kreport.com/company/paieon)
- Rcadia Medical Imaging, Ltd.: 2 (https://510kreport.com/company/rcadia-medical-imaging)

## Its most-cited devices
- K071331: Vitrea Version 4.0 (2007), cited by 15
- K002519: Vitrea 2, Version 2.1 (2000), cited by 13
- K061624: Vitrea, Version 3.9 (2006), cited by 9
- K043333: VITREA2, Version 3.7 Medical Image Processing System (2004), cited by 5
- K052632: VITREA2 Version 3.8 Medical Image Processing Software (2005), cited by 5
- K032748: VITREA2, Version 3.4 Medical Image Processing Software (2003), cited by 4

## Recent decisions
- K181247: Vitrea CT Brain Perfusion (Nov 20, 2018)
- K182230: Multi Modality Viewer (Sep 7, 2018)
- K172855: Vitrea Advanced Visualization, Version 7.6 (Oct 5, 2017)
- K163232: Vitrea View (Jul 21, 2017)
- K163574: Multi Modality Viewer (Jan 26, 2017)
- K161157: Vitrea CT Dual Energy Image View (Nov 3, 2016)
- K161419: Multi Modality Viewer (Jul 13, 2016)
- K160150: Vitrea CT Colon Analysis (Mar 16, 2016)

Source page: https://510kreport.com/company/vital-images