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Sign in to claim this brandMedis Medical Imaging Systems, Inc.
US
Last updated May 24, 2026
Part of Medis Medical Imaging Systems bv
What Medis Medical Imaging Systems, Inc. makes
Medis Medical Imaging Systems, Inc. manufactures cardiovascular measurement systems, including devices designed to assess and analyze heart function and vascular health through imaging and diagnostic tools.
The company’s portfolio is regulated under FDA Class II devices and is listed via the 510(k) clearance pathway. These products are intended for use in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Medis Medical Imaging Systems, Inc. manufacture?
Medis Medical Imaging Systems, Inc. specializes in cardiovascular measurement systems. These devices are designed to evaluate and analyze heart function and vascular health, primarily through imaging and diagnostic tools. The focus is on assisting healthcare providers in assessing cardiovascular conditions.
Where is Medis Medical Imaging Systems, Inc. based?
Medis Medical Imaging Systems, Inc. is based in the United States. The company’s operations and regulatory compliance are aligned with U.S. medical device standards.
Which regulatory registries or databases list Medis Medical Imaging Systems, Inc.’s devices?
Medis Medical Imaging Systems, Inc.’s devices are listed in the FDA’s 510(k) clearance registry. This pathway is used for Class II devices, which require pre-market notification to demonstrate substantial equivalence to a legally marketed predicate device before being placed on the market.
How are Medis Medical Imaging Systems, Inc.’s devices classified by regulatory authorities?
Medis Medical Imaging Systems, Inc.’s devices fall under FDA Class II classification. This classification indicates moderate risk, requiring specific controls to ensure safety and effectiveness. The 510(k) clearance process is the primary regulatory pathway for these devices in the U.S.
AI-generated from registry data and not verified by a human reviewer.
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Catalogue (19)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Medis Suite MRCT | 2018 | FDA UDI | Class II | Active |
| Medis Suite XA | 2021 | FDA UDI | Class II | Active |
| Medis Suite MRCT | 2021 | FDA UDI | Class II | Active |
| Medis Suite MRCT | 2019 | FDA UDI | Class II | Active |
| Medis Suite MRCT | 2.1 | FDA UDI | Class II | Active |
| Medis Suite MRCT | 2020 | FDA UDI | Class II | Active |
| Medis Suite XA 2D | 2019 | FDA UDI | Class II | Active |
| Medis Suite MRCT | 2025 | FDA UDI | Class II | Active |
| Medis Suite XA | 2023 | FDA UDI | Class II | Active |
| Medis Suite MRCT | 3.0 | FDA UDI | Class II | Active |
| Medis Suite XA | 2020 | FDA UDI | Class II | Active |
| QAngio XA | 7.3 | FDA UDI | Class II | Active |
| Medis Suite MRCT | 2023 | FDA UDI | Class II | Active |
| Medis Suite XA 2D | 2018 | FDA UDI | Class II | Active |
| Medis Suite MRCT | 2022 | FDA UDI | Class II | Active |
| QAngio XA 3D | 2.0 | FDA UDI | Class II | Active |
| Medis Suite XA | 2022 | FDA UDI | Class II | Active |
| Barium Enema Tubes: No. 3001000, 3001001, 3001002 | K885092 | FDA 510(k) | Class II | Active |
| Cardiovascular Measurement System-Cms | K940172 | FDA 510(k) | Class II | Active |
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