AccessGUDID - DEVICE: Videa Caries Assist (00196852162192)

GUDID

Device Identifier (DI) Information

Brand Name: Videa Caries Assist
Version or Model: VCA01B
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Videahealth, Inc.

Primary DI Number: 00196852162192
Issuing Agency: GS1
Commercial Distribution End Date: February 09, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 117170604 *Terms of Use

Device Description: 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.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MYN	Analyzer, Medical Image

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K213795	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: fc950bef-2d02-49c4-8e67-afd4cef302eb
Public Version Date: February 10, 2023
Public Version Number: 2
DI Record Publish Date: July 06, 2022