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Sign in to claim this brandTomtec Imaging Systems GmbH
US
Last updated May 25, 2026
Information
- Country
- US
- Address
- —
- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 537711462
Catalogue (31)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Tomtec-Arena | TTA2.40 | FDA UDI | Class II | Unknown |
| Tomtec-Arena | TTA2.41 | FDA UDI | Class II | Active |
| Image-Arena | IA4 | FDA UDI | Class II | Unknown |
| Tomtec-Arena | TTA2.42 | FDA UDI | Class II | Active |
| Tomtec-Arena | TTA2 | FDA UDI | Class II | Active |
| Tomtec-Arena | TTA2.51 | FDA UDI | Class II | Active |
| Tomtec-Arena | TTA2.52 | FDA UDI | Class II | Active |
| Tomtec-Arena | TTA2.50 | FDA UDI | Class II | Active |
| Image-Arena Applications | K083348 | FDA 510(k) | Class II | Active |
| Echo Scan, Easy Scan | K993394 | FDA 510(k) | Class II | Active |
| Tomtec-Arena | K213544 | FDA 510(k) | Class II | Active |
| Image-Arena Applications And Research-Arena Applications | K071232 | FDA 510(k) | Class II | Active |
| Image-Arena And Image-Arena Applications | K110667 | FDA 510(k) | Class II | Active |
| Echo-View 5.x, Easy-View 2.x, Omni View 2.x, Cardio-View 1.x, Lv Analysis 1.x & Surgical View 1.x | K022824 | FDA 510(k) | Class II | Active |
| Image-Arena 4.0 And Ia Applications 2d Cardiac Performance Analysis 1.0 | K090461 | FDA 510(k) | Class II | Active |
| Echo View, Easy View, Omni View | K993398 | FDA 510(k) | Class II | Active |
| Tomtec-Arena | K201632 | FDA 510(k) | Class II | Active |
| Image-Arena And Research-Arena Applications | K040546 | FDA 510(k) | Class II | Active |
| Tomtec-Arena Tta2 | K150122 | FDA 510(k) | Class II | Active |
| 4d Lv-Analysis 3.0 | K110746 | FDA 510(k) | Class II | Active |
| Tomtec-Arena 1.0, Tomtec-Arena 3d Echo, Cardio-Arena | K132544 | FDA 510(k) | Class II | Active |
| 2d Cardiac Performance Analysis Mr 1.0 | K120135 | FDA 510(k) | Class II | Active |
| 4d Mv-Assessment 2.0 | K103782 | FDA 510(k) | Class II | Active |
| Tomtec Echo-Scan | K963807 | FDA 510(k) | Class II | Active |
| Tomtecp90 | K950279 | FDA 510(k) | Class I | Active |
| 4d Sono-Scan 1.0 | K110595 | FDA 510(k) | Class II | Active |
| Image-Arena Applications, Model Image-Arena Va Platform 1.0, 4d Lv-Analysis 2.5, 4d Lv-Analysis Mr 1.0 | K082510 | FDA 510(k) | Class II | Active |
| Panoramic Scan, Panoramic View, Widas, Wide Area Scanning | K003936 | FDA 510(k) | Class II | Active |
| Image-Com 5.0 | K122289 | FDA 510(k) | Class II | Active |
| Sono-Scan, Sono-Scan Pro, Cardio Scan | K020561 | FDA 510(k) | Class II | Active |
| Echocom, Imagecom, Dokucom | K001592 | FDA 510(k) | Class II | Active |
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- TOMTEC Imaging Systems GMBH UNTERSCHLEISSHEIM Bavaria · DE FEI 1000185293