Data / Medical devices / Canada / CDR Systems, Inc.
CDR Systems, Inc.: FDA-registered device maker in Calgary Alberta, Canada, 1 510(k) clearance
CDR Systems, Inc. is registered with the FDA (registration 3009394603) in Calgary Alberta, Canada. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated April 30, 2013. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3009394603
- Address
- 4334 - 110 Ave SE, Calgary Alberta, Canada, T2C 0J6
- Owner or operator
- CDR Systems, Inc. (10044439)
- Roles
- Manufacturer
- First device listed
- June 12, 2013
- Registered through
- 2026
- Brand names listed
- CDR Systems Precision Patient Positioning System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accelerator, Linear, Medical | IYE | 2 | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| April 30, 2013 | K122888 | CDR SYSTEMS PRECISION PATIENT POSITIONING SYSTEM | IYE | Substantially Equivalent | Cdr Systems, Inc. | accessdata.fda.gov |
Compare with other makers
Updated April 30, 2013. 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.