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Sign in to claim this brandConvergent Imaging Solutions Incorporated
US
Last updated May 30, 2026
What Convergent Imaging Solutions Incorporated makes
Convergent Imaging Solutions Incorporated manufactures radiology picture archiving and communication system (PACS) workstations, including the UniSyn platform, designed for medical imaging data management and display.
The company’s products are classified as Class II devices under FDA regulations and are listed in the FDA’s Unique Device Identifier (UDI) database. The manufacturer is based 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 Convergent Imaging Solutions Incorporated manufacture?
Convergent Imaging Solutions Incorporated specializes in radiology picture archiving and communication system (PACS) workstations. These devices are primarily used for managing, storing, and displaying medical imaging data, such as X-rays, MRIs, and CT scans, to streamline workflows in healthcare settings. The UniSyn platform is an example of their PACS workstation product.
Where is Convergent Imaging Solutions Incorporated based?
The company is headquartered in the United States. This location is relevant for understanding regulatory oversight, as it falls under the jurisdiction of the U.S. Food and Drug Administration (FDA) for device authorization and compliance.
How are the devices manufactured by Convergent Imaging Solutions Incorporated classified under FDA regulations?
The devices produced by Convergent Imaging Solutions Incorporated are classified as Class II under FDA regulations. This classification typically applies to devices that pose moderate risk and require special controls to ensure their safety and effectiveness, such as PACS workstations that manage sensitive medical imaging data.
Are the devices from Convergent Imaging Solutions Incorporated listed in any regulatory registries?
Yes, the company’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. The UDI system helps track and identify medical devices throughout their distribution and use, ensuring transparency and traceability for regulatory and clinical purposes.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- convergentimaging.com
- —
- —
- [email protected]
- Phone
- 613-212-0063
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 242364082
Catalogue (22)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| UniSyn | 4-2-5-P2 | FDA UDI | Class II | Unknown |
| UniSyn | 7-3-3-PX | FDA UDI | Class II | Unknown |
| UniSyn | 6-2-4-PX | FDA UDI | Class II | Unknown |
| UniSyn | 6-2-6-PX | FDA UDI | Class II | Unknown |
| UniSyn | 6-1-1-PX | FDA UDI | Class II | Unknown |
| UniSyn | 6-2-2-PX | FDA UDI | Class II | Unknown |
| UniSyn | 5-4-1-PX | FDA UDI | Class II | Unknown |
| UniSyn | 6-2-5-PX | FDA UDI | Class II | Unknown |
| UniSyn | 7-2-1-PX | FDA UDI | Class II | Unknown |
| UniSyn | 5-6-1-PX | FDA UDI | Class II | Unknown |
| UniSyn | 5-5-2-PX | FDA UDI | Class II | Unknown |
| UniSyn | 4-3-1-P1 | FDA UDI | Class II | Unknown |
| UniSyn | 6-2-3-PX | FDA UDI | Class II | Unknown |
| UniSyn | 5-5-1-PX | FDA UDI | Class II | Unknown |
| UniSyn | 6-2-1-PX | FDA UDI | Class II | Unknown |
| UniSyn | 7-1-1-PX | FDA UDI | Class II | Unknown |
| UniSyn | 7-4-1-PX | FDA UDI | Class II | Active |
| UniSyn | 7-3-2-PX | FDA UDI | Class II | Unknown |
| UniSyn | 7-5-1-PX | FDA UDI | Class II | Active |
| UniSyn | 7-3-4-PX | FDA UDI | Class II | Unknown |
| UniSyn | 7-3-1-PX | FDA UDI | Class II | Unknown |
| UniSyn | 5-3-1-P2 | FDA UDI | Class II | Unknown |
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