Data / Medical devices / Canada / Convergent Imaging Solutions
Convergent Imaging Solutions: FDA-registered device maker in Ottawa Ontario, Canada, 4 510(k) clearances
Convergent Imaging Solutions is registered with the FDA (registration 3014954414) in Ottawa Ontario, Canada. It lists 3 device types. The FDA files 4 510(k) clearances under its listings, the newest dated September 1, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3014954414
- Address
- 36 Rideau River Ln, Ottawa Ontario, Canada, K1S 0X1
- Owner or operator
- Convergent Imaging Solutions (10061589)
- Roles
- Exporter to the US, Manufacturer
- First device listed
- December 9, 2019
- Registered through
- 2026
- Brand names listed
- CSMC Cardiac Suite v2017, NeuroQ, UniSyn, UniSyn Molecular Imaging
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Camera, Scintillation (Gamma) | IYX | 1 | Manufacturer | accessdata.fda.gov |
| System, Image Processing, Radiological | LLZ | 2 | Manufacturer | accessdata.fda.gov |
| System, Tomography, Computed, Emission | KPS | 2 | Exporter to the US | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 1, 2023 | K231047 | UniSyn Molecular Imaging (6-3-1) | LLZ | Substantially Equivalent | Convergent Imaging Solutions | accessdata.fda.gov |
| August 16, 2018 | K180077 | NeuroQ 3.8 | KPS | Substantially Equivalent | Syntermed | accessdata.fda.gov |
| November 3, 2017 | K172609 | CSMC Cardiac Suite | KPS | Substantially Equivalent | Cedars-Sinai Medical Center | accessdata.fda.gov |
| September 26, 2008 | K081987 | UNISYN IMAGE FUSION, VERSION 1.0 | LLZ | Substantially Equivalent | Convergent Imaging Solutions | accessdata.fda.gov |
Compare with other makers
- All makers of System, Tomography, Computed, Emission
- All makers of System, Image Processing, Radiological
- All makers of Camera, Scintillation (Gamma)
Updated September 1, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.