Videa Caries Assist

GUDID 00196852162192

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.

Videahealth, Inc.

Dental x-ray image interpretive software
Primary Device ID00196852162192
NIH Device Record Keyfc950bef-2d02-49c4-8e67-afd4cef302eb
Commercial Distribution StatusIn Commercial Distribution
Brand NameVidea Caries Assist
Version Model NumberVCA01B
Company DUNS117170604
Company NameVideahealth, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone(617)340-9940
Emailsupport@videa.ai
Phone(617)340-9940
Emailsupport@videa.ai
Phone(617)340-9940
Emailsupport@videa.ai
Phone(617)340-9940
Emailsupport@videa.ai
Phone(617)340-9940
Emailsupport@videa.ai
Phone(617)340-9940
Emailsupport@videa.ai
Phone(617)340-9940
Emailsupport@videa.ai
Phone(617)340-9940
Emailsupport@videa.ai
Phone(617)340-9940
Emailsupport@videa.ai
Phone(617)340-9940
Emailsupport@videa.ai
Phone(617)340-9940
Emailsupport@videa.ai
Phone(617)340-9940
Emailsupport@videa.ai
Phone(617)340-9940
Emailsupport@videa.ai
Phone(617)340-9940
Emailsupport@videa.ai
Phone(617)340-9940
Emailsupport@videa.ai
Phone(617)340-9940
Emailsupport@videa.ai
Phone(617)340-9940
Emailsupport@videa.ai
Phone(617)340-9940
Emailsupport@videa.ai
Phone(617)340-9940
Emailsupport@videa.ai
Phone(617)340-9940
Emailsupport@videa.ai
Phone(617)340-9940
Emailsupport@videa.ai
Phone(617)340-9940
Emailsupport@videa.ai

Device Identifiers

Device Issuing AgencyDevice ID
GS100196852162192 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MYNAnalyzer, Medical Image

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-07-14
Device Publish Date2022-07-06

Devices Manufactured by Videahealth, Inc.

00860009836822 - Videa Dental Assist2024-01-23 Videa Dental Assist is a computer-assisted detection (CADe) device that analyzes intraoral radiographs to identify and localize
00196852162192 - Videa Caries Assist2022-07-14Videa 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 Assist2022-07-14 Videa Caries Assist is a computer-assisted detection (CADe) device that analyzes intraoral radiographs to identify and localize

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.