Data / Medical devices / United States / Ortho2
Ortho2: FDA-registered device maker in Ames, IA, United States, 1 510(k) clearance
Ortho2 is registered with the FDA (registration 3009149931) in Ames, IA, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated October 17, 2019. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3009149931
- Address
- 1107 Buckeye Ave, Ames, IA, United States, 50010
- Owner or operator
- Ortho2 (10061548)
- Roles
- Manufacturer
- First device listed
- October 28, 2019
- Registered through
- 2026
- Brand names listed
- Premier Imaging, SmartCeph
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, Image Processing, Radiological | LLZ | 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 |
|---|---|---|---|---|---|---|
| October 17, 2019 | K190162 | SmartCeph | LLZ | Substantially Equivalent | Ortho2, LLC | accessdata.fda.gov |
Compare with other makers
Updated October 17, 2019. 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.