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Sign in to claim this brandVideahealth, Inc.
US
Last updated September 17, 2026
What Videahealth, Inc. makes
Videahealth, Inc. develops software for interpreting dental X-ray images, including tools for caries detection, periodontal assessment, and automated diagnostic support. Products like Videa Dental Assist, Videa Perio Assist, and Videa Caries Assist analyze radiographic scans to assist clinicians in identifying dental issues. Additional offerings, such as Videa Dental AI, leverage artificial intelligence to enhance diagnostic accuracy for dental professionals.
The company’s software portfolio is classified as Class II medical devices under FDA regulations. These products are authorised via the 510(k) premarket notification process and are listed in the FDA’s Unique Device Identifier (UDI) database. The manufacturer operates from the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Videahealth, Inc. manufacture?
Videahealth, Inc. specializes in dental x-ray image interpretive software. Their products focus on assisting dental professionals with diagnostic tasks, such as detecting caries (tooth decay), assessing periodontal health, and providing automated diagnostic support through AI-driven tools like Videa Dental AI, Videa Caries Assist, and Videa Perio Assist.
Where is Videahealth, Inc. based, and how does that affect its regulatory standing?
Videahealth, Inc. is based in the United States. Since the company operates within the US, its devices are subject to FDA regulations, including the 510(k) premarket notification process for Class II medical devices. This classification means their software solutions require regulatory authorisation before commercial distribution in the US market.
Which regulatory registries list Videahealth, Inc.’s devices, and why?
Videahealth, Inc.’s devices are listed in the FDA’s 510(k) premarket notification database and the FDA’s Unique Device Identifier (UDI) database. The 510(k) process confirms that their Class II software meets FDA safety and effectiveness requirements, while the UDI database ensures traceability and transparency in the supply chain for regulated medical devices.
How are Videahealth, Inc.’s devices classified under medical device regulations?
Videahealth, Inc.’s dental x-ray interpretive software is classified as Class II medical devices by the FDA. This classification applies because the software modifies the performance of a device (in this case, dental X-ray systems) in a way that could affect patient safety or clinical outcomes, requiring premarket review to ensure proper functionality and risk management.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- 281 Summer St Fl 6, Boston, MA, 02210
- Website
- videa.ai
- —
- —
- [email protected]
- Phone
- (617) 299-1871
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 3022719380
- DUNS Number
- 117170604
Catalogue (8)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Videa Dental Assist | VDA01BPN | FDA UDI | Class II | Active |
| Videa Caries Assist | VCA01B | FDA UDI | Class II | Unknown |
| Videa Caries Assist | VCA01B | FDA UDI | Class II | Unknown |
| Videa Perio Assist | VPA01BP | FDA UDI | Class II | Active |
| Videa Perio Assist | K223296 | FDA 510(k) | Class II | Active |
| Videa Dental AI | K251002 | FDA 510(k) | Class II | Active |
| Videa Caries Assist | K213795 | FDA 510(k) | Class II | Active |
| Videa Dental Assist | K232384 | FDA 510(k) | Class II | Active |
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