Data / Medical devices / United States / Planet DDS
Planet DDS: FDA-registered device maker in Akron, OH, United States, 3 510(k) clearances
Planet DDS is registered with the FDA (registration 3007350723) in Akron, OH, United States. It lists 1 device type. The FDA files 3 510(k) clearances under its listings, the newest dated November 30, 2018. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3007350723
- Address
- 159 S Main St Ste 414, Akron, OH, United States, 44308
- Owner or operator
- Planet DDS (9034217)
- Roles
- Manufacturer
- First device listed
- November 17, 2011
- Registered through
- 2026
- Brand names listed
- XVWeb, XVWeb 3D, XVlite, XrayVision, XrayVision DCV
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 |
|---|---|---|---|---|---|---|
| November 30, 2018 | K182815 | XVWeb 3D | LLZ | Substantially Equivalent | Apteryx, Inc. | accessdata.fda.gov |
| December 20, 2013 | K132342 | XVWEB | LLZ | Substantially Equivalent | Apteryx, Inc. | accessdata.fda.gov |
| November 16, 1998 | K983111 | XRAY VISION | LLZ | Substantially Equivalent | Apteryx, Inc. | accessdata.fda.gov |
Compare with other makers
Updated November 30, 2018. 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.