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

Upcoming Training

62304, FDA, and Emerging Standards for Medical Device and HealthIT
Planned Instructors:  Brian Pate, John F. Murray, Jr
Location: Sunnyvale, CA, USA
Dates:  February 4-6, 2020

QSS Software Validation
Planned Instructors:  Brian Pate, John F. Murray, Jr
Location: Boston, MA, USA
Dates:  June 2-4, 2020

To pre-register and get info on deep discounts or if you have questions, email training@softwarecpr.com

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