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FDA 510(k)

DBSWIN and VistaEasy Imaging Software

K-Number: K161444 · 2016-06-21

ApplicantDuerr Dental AG
Decision Date2016-06-21
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

DBSWIN and VistaEasy Imaging Software is a medical device manufactured by Duerr Dental AG. It received FDA 510(k) clearance on 2016-06-21 under approval number K161444. 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 2016-06-21. It is manufactured by Duerr Dental AG. The 510(k) number is K161444.

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

DBSWIN and VistaEasy Imaging Software received FDA 510(k) clearance on 2016-06-21, under approval number K161444.

What company makes DBSWIN and VistaEasy Imaging Software?

DBSWIN and VistaEasy Imaging Software is manufactured by Duerr 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: 41938602 AI-enabled cardiovascular devices: a lifecycle playbook for evidence, change control, and post-market assurance. Frontiers in digital health (2026) PMID: 41883556 A clinician's quick‑start guide to implementing digital health innovations in the NHS - with lessons from a UK-deployed AI stroke imaging decision-support software. Digital health (2026) PMID: 41476571 Digital pathology imaging artificial intelligence in cancer research and clinical trials: An NCI workshop report. Journal of pathology informatics (2026)

Other Devices by Duerr Dental AG

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Official Source

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