Inc. Denttio

Company: Denttio, Inc.
Product: digital x-ray image receptors and intraoral microscope/cameras
Date:2/23/2017

Failure to perform device software validation and risk analysis as required by 21 CFR 820.30(g). For example, you do not have records to demonstrate that your Imaging Software used with the Tio-H Digital X-Ray Sensor has been validated. You do not have records to demonstrate that your firm has conducted a risk analysis to identify potential hazards and control measures with the Tio-H Digital X-Ray Sensor System.

FDA District: Los Angeles District

About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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