Primary Device ID | 00196852162192 |
NIH Device Record Key | fc950bef-2d02-49c4-8e67-afd4cef302eb |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Videa Caries Assist |
Version Model Number | VCA01B |
Company DUNS | 117170604 |
Company Name | Videahealth, Inc. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | false |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | false |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Phone | (617)340-9940 |
support@videa.ai | |
Phone | (617)340-9940 |
support@videa.ai | |
Phone | (617)340-9940 |
support@videa.ai | |
Phone | (617)340-9940 |
support@videa.ai | |
Phone | (617)340-9940 |
support@videa.ai | |
Phone | (617)340-9940 |
support@videa.ai | |
Phone | (617)340-9940 |
support@videa.ai | |
Phone | (617)340-9940 |
support@videa.ai | |
Phone | (617)340-9940 |
support@videa.ai | |
Phone | (617)340-9940 |
support@videa.ai | |
Phone | (617)340-9940 |
support@videa.ai | |
Phone | (617)340-9940 |
support@videa.ai | |
Phone | (617)340-9940 |
support@videa.ai | |
Phone | (617)340-9940 |
support@videa.ai | |
Phone | (617)340-9940 |
support@videa.ai | |
Phone | (617)340-9940 |
support@videa.ai | |
Phone | (617)340-9940 |
support@videa.ai | |
Phone | (617)340-9940 |
support@videa.ai | |
Phone | (617)340-9940 |
support@videa.ai | |
Phone | (617)340-9940 |
support@videa.ai | |
Phone | (617)340-9940 |
support@videa.ai | |
Phone | (617)340-9940 |
support@videa.ai |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00196852162192 [Primary] |
MYN | Analyzer, Medical Image |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2022-07-14 |
Device Publish Date | 2022-07-06 |
00860009836822 - Videa Dental Assist | 2024-01-23 Videa Dental Assist is a computer-assisted detection (CADe) device that analyzes intraoral radiographs to identify and localize |
00196852162192 - Videa Caries Assist | 2022-07-14Videa 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. |
00196852162192 - Videa Caries Assist | 2022-07-14 Videa Caries Assist is a computer-assisted detection (CADe) device that analyzes intraoral radiographs to identify and localize |