FDA UDI
In Commercial Distribution
🇺🇸 United States
Videa Dental Assist
DI: 00860009836822
·
Model: VDA01BPN
·
Videahealth, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Videa Dental Assist
- Primary DI
- 00860009836822
- Version / Model
- VDA01BPN
- Company Name
- Videahealth, Inc.
- Labeler DUNS
- 117170604
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-01-15
- Public Version
- 1
- Public Version Date
- 2024-01-23
- Public Version Status
- New
- Public Device Record Key
- 2a281813-a611-43db-8788-73c708a4b826
Device Description
Videa Dental Assist is a computer-assisted detection (CADe) device that analyzes intraoral radiographs to identify and localize suspect dental finding, historical treatment and normal anatomy features. Videa Dental Assist is indicated for the review of bitewing, periapical, and panoramic radiographs acquired from patients aged 3 years or older.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MYN | Analyzer, Medical Image | Radiology | 892.2070 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 65472 | Dental x-ray image interpretive software | An interpretive software program intended to be used to analyse dental x-ray images (e.g., panoramic and bitewing) to facilitate the localization and classification of teeth, detect abnormalities (e.g., caries, apical lesion), and identify past dental procedures (e.g., fillings, crowns, bridges, implants); it utilizes artificial intelligence (AI)/deep learning algorithms. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00860009836822 | GS1 |
Customer Contacts
- Phone
- (617)299-1871
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K232384 | 000 |