Data / Medical devices / United States / Paxerahealth Corp
Paxerahealth Corp: FDA-registered device maker in Newton, MA, United States, 1 510(k) clearance
Paxerahealth Corp is registered with the FDA (registration 3009341091) in Newton, MA, United States. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated October 31, 2013. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3009341091
- Address
- 85 Wells Ave Ste 120, Newton, MA, United States, 02459
- Owner or operator
- PaxeraHealth (10038120)
- Roles
- Manufacturer
- First device listed
- September 16, 2011
- Registered through
- 2026
- Brand names listed
- ARK3, Paxera AI, Paxera ARK AI, Paxera PACS, Paxera VNA, PaxeraPACS, PaxeraUltima, PaxeraUltima360 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Device, Digital Image Storage, Radiological | LMB | 1 | Manufacturer | accessdata.fda.gov |
| 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 31, 2013 | K132586 | PAXERAPACS | LLZ | Substantially Equivalent | Paxeramed | accessdata.fda.gov |
Compare with other makers
- All makers of Device, Digital Image Storage, Radiological
- All makers of System, Image Processing, Radiological
Updated October 31, 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.