Data / Medical devices / United States / Cuattro Imaging, LLC
Cuattro Imaging, LLC: FDA-registered device maker in Avon, CO, United States, 1 510(k) clearance
Cuattro Imaging, LLC is registered with the FDA (registration 3008364043) in Avon, CO, United States. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated October 6, 2016. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3008364043
- Address
- 910 Nottingham Ranch Rd Ste N-11, Avon, CO, United States, 81620
- Owner or operator
- Cuattro Imaging, LLC (10032085)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- May 17, 2017
- Registered through
- 2026
- Brand names listed
- CuattroDR Medical or CuattroDR MD
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, Image Processing, Radiological | LLZ | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| System, X-Ray, Stationary | KPR | 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 6, 2016 | K161937 | CuattroDR | KPR | Substantially Equivalent | Cuattro, LLC | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| October 15, 2019 | 85446 | Class II | Terminated | CuattroDR System Software, REF: SWR-00069-MD, UDI: B269SWR00069MD0 | There is a potential that an image from a previous patient study to show up in a later patient study. This may result in misdiagnosis of the correct patient. | accessdata.fda.gov |
Compare with other makers
Updated October 6, 2016. 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.