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FDA 510(k)

DBSWIN and VISTAEASY Imaging Software

K-Number: K190629 · 2019-04-01

ApplicantDurr Dental SE
Decision Date2019-04-01
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

DBSWIN and VISTAEASY Imaging Software is a medical device manufactured by Durr Dental SE. It received FDA 510(k) clearance on 2019-04-01 under approval number K190629. 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 2019-04-01. It is manufactured by Durr Dental SE. The 510(k) number is K190629.

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

DBSWIN and VISTAEASY Imaging Software received FDA 510(k) clearance on 2019-04-01, under approval number K190629.

What company makes DBSWIN and VISTAEASY Imaging Software?

DBSWIN and VISTAEASY Imaging Software is manufactured by Durr Dental SE.

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)

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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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