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FDA 510(k)

TIO-H DIGITAL RADIOGRAPHY SENSOR

K-Number: K153144 · 2016-02-10

ApplicantDenttio, Inc.
Decision Date2016-02-10
Product CodeMUH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

TIO-H DIGITAL RADIOGRAPHY SENSOR is a medical device manufactured by Denttio, Inc.. It received FDA 510(k) clearance on 2016-02-10 under approval number K153144. The device is classified under product code MUH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TIO-H DIGITAL RADIOGRAPHY SENSOR?

TIO-H DIGITAL RADIOGRAPHY SENSOR is a medical device that received FDA 510(k) clearance on 2016-02-10. It is manufactured by Denttio, Inc.. The 510(k) number is K153144.

When was TIO-H DIGITAL RADIOGRAPHY SENSOR approved by the FDA?

TIO-H DIGITAL RADIOGRAPHY SENSOR received FDA 510(k) clearance on 2016-02-10, under approval number K153144.

What company makes TIO-H DIGITAL RADIOGRAPHY SENSOR?

TIO-H DIGITAL RADIOGRAPHY SENSOR is manufactured by Denttio, Inc..

What is the FDA product code for TIO-H DIGITAL RADIOGRAPHY SENSOR?

The FDA product code for TIO-H DIGITAL RADIOGRAPHY SENSOR is MUH.

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Related PubMed Literature

PMID: 40942702 Digital Cardiovascular Twins, AI Agents, and Sensor Data: A Narrative Review from System Architecture to Proactive Heart Health. Sensors (Basel, Switzerland) (2025)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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