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Sign in to claim this brandWhat Mach7 Technologies Canada Inc makes
Mach7 Technologies Canada Inc develops radiological Picture Archiving and Communication Systems (PACS) software, designed to manage, store, and distribute medical imaging data within healthcare facilities. Their solutions facilitate secure access, retrieval, and sharing of digital images and reports across clinical workflows, supporting diagnostic and treatment processes.
The company’s PACS software is classified as Class II under FDA regulations and is listed in the FDA’s Unique Device Identifier (UDI) database. The manufacturer operates from 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 Mach7 Technologies Canada Inc manufacture?
Mach7 Technologies Canada Inc specializes in developing radiological Picture Archiving and Communication Systems (PACS) software. These systems are designed to manage, store, and securely distribute medical imaging data, enabling healthcare providers to access, retrieve, and share digital images and reports efficiently. This supports critical workflows in diagnostics and treatment planning.
Where is Mach7 Technologies Canada Inc based?
Mach7 Technologies Canada Inc operates from the United States. While the company name includes 'Canada,' its primary operational base and regulatory presence are in the US.
Which regulatory registries list devices manufactured by Mach7 Technologies Canada Inc?
Mach7 Technologies Canada Inc’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify their Class II radiological PACS software, ensuring transparency and traceability for healthcare professionals and regulators.
How are the devices produced by Mach7 Technologies Canada Inc classified under FDA regulations?
Mach7 Technologies Canada Inc’s radiological PACS software is classified as Class II under FDA regulations. This classification is based on the device’s intended use—managing medical imaging data—and its associated risk level, which requires special controls to ensure safety and effectiveness without needing pre-market approval.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 243312163
Catalogue (1)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| eUnity | eUnity-1 | EUDAMEDFDA UDI | Class II | Active |
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