Data / Medical devices / United States / VideaHealth, Inc.
VideaHealth, Inc.: FDA-registered device maker in Boston, MA, United States, 2 510(k) clearances
VideaHealth, Inc. is registered with the FDA (registration 3022719380) in Boston, MA, United States. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated December 15, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3022719380
- Address
- 281 Summer St Fl 6, Boston, MA, United States, 02210
- Owner or operator
- VideaHealth, Inc. (10085186)
- Roles
- Manufacturer
- First device listed
- February 7, 2023
- Registered through
- 2026
- Brand names listed
- Caries 3, Dentrix Detect, Dentrix Detect Ascend, Dentrix Detect Enterprise, Videa Dental AI, Videa Perio Assist
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Analyzer, Medical Image | MYN | 2 | Manufacturer | accessdata.fda.gov |
| Automated Radiological Image Processing Software | QIH | 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 |
|---|---|---|---|---|---|---|
| December 15, 2023 | K232384 | Videa Dental Assist | MYN | Substantially Equivalent | Videahealth, Inc. | accessdata.fda.gov |
| February 6, 2023 | K223296 | Videa Perio Assist | QIH | Substantially Equivalent | Videahealth, Inc. | accessdata.fda.gov |
Compare with other makers
Updated December 15, 2023. 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.