# Tomtec Imaging Systems GmbH

- Location (FDA's records): Unterschleissheim, DE
- FDA decisions: 23 (1995–2022): 23 510(k) clearances
- Names in FDA's records: Tomtec Imaging Systems GmbH (21); Tomtec Imaging Systems, Inc. (2)
- Product codes: LLZ (13), IYO (5), DQK (3), QIH (1), LMB (1)
- Predicates its devices cite: 42 (31 its own); citations of its devices by later devices: 68 (31 its own)
- Recalls linked to its devices: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Philips Medical Systems North America, Inc.: 2 (https://510kreport.com/company/philips-medical-systems-north-america)
- Acuson Corp.: 1 (https://510kreport.com/company/acuson)
- Siemens Medical Solutions USA, Inc.: 1 (https://510kreport.com/company/siemens-medical-solutions-usa)
- Siemens Medical Solutions USA, Inc., Ultrasound DI: 1 (https://510kreport.com/company/siemens-medical-solutions-usa-ultrasound-di)
- Philips Health Care: 1 (https://510kreport.com/company/philips-health-care)
- Diagnosoft, Inc.: 1 (https://510kreport.com/company/diagnosoft)
- Tomtec Tomographic Technologies GmbH: 1 (https://510kreport.com/company/tomtec-tomographic-technologies)
- Toshiba America Medical Systems, In.C: 1 (https://510kreport.com/company/toshiba-america-medical-systems-in-c)

## Firms that cite its devices most
- Philips Ultrasound, Inc.: 3 (https://510kreport.com/company/philips-ultrasound)
- Toshiba America Medical Systems, In.C: 2 (https://510kreport.com/company/toshiba-america-medical-systems-in-c)
- Mpacs, LLC: 2 (https://510kreport.com/company/mpacs)
- GE Medical Systems Ultrasound and Primary Care Diagnostics: 2 (https://510kreport.com/company/ge-medical-systems-ultrasound-and-primary-care-diagnostics)
- Pie Medical Imaging BV: 2 (https://510kreport.com/company/pie-medical-imaging)
- Argus Cognitive, Inc.: 2 (https://510kreport.com/company/argus-cognitive)
- Volcano Therapeutics, Inc.: 2 (https://510kreport.com/company/volcano-therapeutics)
- Echotech 3D Imaging Systems, Inc.: 2 (https://510kreport.com/company/echotech-3d-imaging-systems)

## Its most-cited devices
- K071232: Image-Arena Applications and Research-Arena Applications (2007), cited by 8
- K150122: Tomtec-Arena TTA2 (2015), cited by 7
- K963807: Tomtec Echo-Scan (1996), cited by 7
- K040546: Image-Arena and Research-Arena Applications (2004), cited by 5
- K090461: Image-Arena 4.0 and IA Applications 2D Cardiac Performance Analysis 1.0 (2009), cited by 4
- K201632: Tomtec-Arena (2020), cited by 4

## Recent decisions
- K213544: Tomtec-Arena (Jan 6, 2022)
- K201632: Tomtec-Arena (Aug 14, 2020)
- K150122: Tomtec-Arena TTA2 (Feb 13, 2015)
- K132544: Tomtec-Arena 1.0, Tomtec-Arena 3D Echo, Cardio-Arena (Nov 25, 2013)
- K122289: Image-Com 5.0 (Oct 24, 2012)
- K120135: 2D Cardiac Performance Analysis MR 1.0 (Apr 13, 2012)
- K110746: 4D LV-Analysis 3.0 (May 24, 2011)
- K110667: Image-Arena and Image-Arena Applications (Apr 8, 2011)

Source page: https://510kreport.com/company/tomtec-imaging-systems