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FDA 510(k)

DBSWIN and VistaEasy Imaging Software

K-Number: K143290 · 2016-02-18

ApplicantDurr Dental AG
Decision Date2016-02-18
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

DBSWIN and VistaEasy Imaging Software is a medical device manufactured by Durr Dental AG. It received FDA 510(k) clearance on 2016-02-18 under approval number K143290. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DBSWIN and VistaEasy Imaging Software?

DBSWIN and VistaEasy Imaging Software is a medical device that received FDA 510(k) clearance on 2016-02-18. It is manufactured by Durr Dental AG. The 510(k) number is K143290.

When was DBSWIN and VistaEasy Imaging Software approved by the FDA?

DBSWIN and VistaEasy Imaging Software received FDA 510(k) clearance on 2016-02-18, under approval number K143290.

What company makes DBSWIN and VistaEasy Imaging Software?

DBSWIN and VistaEasy Imaging Software is manufactured by Durr Dental AG.

What is the FDA product code for DBSWIN and VistaEasy Imaging Software?

The FDA product code for DBSWIN and VistaEasy Imaging Software is LLZ.

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Related PubMed Literature

PMID: 42127793 Ethical Responsibility in the Off-Label Use of AI in Medical Imaging. The Journal of clinical ethics (2026) PMID: 41476571 Digital pathology imaging artificial intelligence in cancer research and clinical trials: An NCI workshop report. Journal of pathology informatics (2026) PMID: 32530098 Introduction to artificial intelligence in ultrasound imaging in obstetrics and gynecology. Ultrasound in obstetrics & gynecology : the official journal of the International Society of Ultrasound in Obstetrics and Gynecology (2020)

Other Devices by Durr Dental AG

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Official Source

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