videa.aiVidea Dental Assist
Videahealth, Inc.
VideaHealth, Inc.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3022719380 | 3022719380 | VideaHealth, Inc. | 1 | N | 2026-01-01 | 281 Summer St Fl 6 Boston MA US 02210 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00196852162192 | Videa Caries Assist - Videa Caries Assist is a computer-assisted detection (CADe) device that analyzes intraoral radiographs to identify and localize carious lesions.Videa Caries Assist is indicated for the review of bitewing (BW) radiographs acquired from adult patients aged 22 years or older. | (617)340-9940 | support@videa.ai |
| 00860009836808 | Videa Caries Assist - Videa Caries Assist is a computer-assisted detection (CADe) device that analyzes intraoral radiographs to identify and localize carious lesions.Videa Caries Assist is indicated for the review of bitewing (BW) radiographs acquired from adult patients aged 22 years or older. | (617)299-1871 | support@videa.ai |
| 00860009836815 | Videa Perio Assist - Videa Perio Assist is a radiological semi-automated image processing software device intended to aid dental professionals in the measurements and visualization of mesial and distal bone levels associated with each tooth from bitewing and periapical radiographs. Measurements are made available as linear distances or relative percentages. | (617) 299-1871 | support@videa.ai |
| 00860009836822 | Videa Dental Assist - Update: Now commercialized under the brand name 'Videa Dental AI'.Videa Dental AI 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. | (617)299-1871 | support@videa.ai |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 305880 | 1932926008 | K232384 | Videa Dental Assist | MYN | 2023-12-15 |
| 305880 | 1039161396 | K223296 | Videa Perio Assist | QIH | 2023-02-06 |
Product Codes Associated With Registrations#
PMN#
GUDID#
Videa Caries Assist - Videa Caries Assist is a computer-assisted detection (CADe) device that analyzes intraoral radiographs to identify and localize carious lesions.Videa Caries Assist is indicated for the review of bitewing (BW) radiographs acquired from adult patients aged 22 years or older.
2023-01-23
Videa Dental Assist - Update: Now commercialized under the brand name 'Videa Dental AI'.Videa Dental AI 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.
2024-01-15
Videa Perio Assist - Videa Perio Assist is a radiological semi-automated image processing software device intended to aid dental professionals in the measurements and visualization of mesial and distal bone levels associated with each tooth from bitewing and periapical radiographs. Measurements are made available as linear distances or relative percentages.
2023-02-13
Videa Caries Assist - Videa Caries Assist is a computer-assisted detection (CADe) device that analyzes intraoral radiographs to identify and localize carious lesions.Videa Caries Assist is indicated for the review of bitewing (BW) radiographs acquired from adult patients aged 22 years or older.
2022-07-06