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FDA 510(k)

Televere Digital Dental Imaging System

K-Number: K181358 · 2018-06-20

ApplicantTelevere Systems, Inc.
Decision Date2018-06-20
Product CodeMUH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Televere Digital Dental Imaging System is a medical device manufactured by Televere Systems, Inc.. It received FDA 510(k) clearance on 2018-06-20 under approval number K181358. 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 Televere Digital Dental Imaging System?

Televere Digital Dental Imaging System is a medical device that received FDA 510(k) clearance on 2018-06-20. It is manufactured by Televere Systems, Inc.. The 510(k) number is K181358.

When was Televere Digital Dental Imaging System approved by the FDA?

Televere Digital Dental Imaging System received FDA 510(k) clearance on 2018-06-20, under approval number K181358.

What company makes Televere Digital Dental Imaging System?

Televere Digital Dental Imaging System is manufactured by Televere Systems, Inc..

What is the FDA product code for Televere Digital Dental Imaging System?

The FDA product code for Televere Digital Dental Imaging System is MUH.

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Related PubMed Literature

PMID: 42204020 A Minimal UDI-DICOM Mapping Profile and Validation Artifact for Medical-Device Imaging Workflows. Journal of imaging informatics in medicine (2026) PMID: 41476571 Digital pathology imaging artificial intelligence in cancer research and clinical trials: An NCI workshop report. Journal of pathology informatics (2026) PMID: 40775988 B-onic Suite: An Integrated Platform for Personalized Medical Devices, Real-Time Surgical Planning, and Enhanced Intraoperative Navigation. Studies in health technology and informatics (2025) PMID: 33371797 Developing a Qualification and Verification Strategy for Digital Tissue Image Analysis in Toxicological Pathology. Toxicologic pathology (2021)

Other Devices by Televere Systems, Inc.

K180765Televere Podiatry X-Ray System HF

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Official Source

View on FDA Database →

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