Data / Medical devices / Canada / CD Newco Canada Inc.
CD Newco Canada Inc.: FDA-registered device maker in Calgary Alberta, Canada, 3 510(k) clearances
CD Newco Canada Inc. is registered with the FDA (registration 3009246966) in Calgary Alberta, Canada. It lists 1 device type. The FDA files 3 510(k) clearances under its listings, the newest dated October 18, 2017. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3009246966
- Address
- 700 2 Street SW, Floor 19, Calgary Alberta, Canada, T2P2W2
- Owner or operator
- CD Newco LLC (10041953)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- September 24, 2012
- Registered through
- 2026
- Brand names listed
- Curve Image 2, Curve Image 2 PACS, Curve Imaging
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, Image Processing, Radiological | LLZ | 2 | Complaint file establishment, 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 |
|---|---|---|---|---|---|---|
| October 18, 2017 | K173101 | Curve Image 2.0 PACS | LLZ | Substantially Equivalent | Curve Dental, Ltd. | accessdata.fda.gov |
| October 20, 2011 | K112974 | PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM | LLZ | Substantially Equivalent | Curve Dental, Inc. | accessdata.fda.gov |
| April 21, 2011 | K110139 | CURVE IMAGE | LLZ | Substantially Equivalent | Curve Dental, Inc. | accessdata.fda.gov |
Compare with other makers
Updated October 18, 2017. 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.