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FDA 510(k)

VISIA

K-Number: K120207 · 2012-04-23

Decision Date2012-04-23
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

VISIA is the device name listed in this FDA 510(k) record. The listed applicant is MeVis Medical Solutions AG. It received FDA 510(k) clearance on 2012-04-23 under 510(k) number K120207. 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 VISIA?

VISIA is a medical device that received FDA 510(k) clearance on 2012-04-23. The listed applicant is MeVis Medical Solutions AG. The 510(k) number is K120207.

When did VISIA receive FDA 510(k) clearance?

VISIA received FDA 510(k) clearance on 2012-04-23, under 510(k) number K120207.

Who is the listed applicant for VISIA?

The FDA 510(k) record lists MeVis Medical Solutions AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VISIA?

The FDA product code for VISIA is LLZ.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Other records listing MeVis Medical Solutions AG as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

View all 7 devices →

Related Devices (Code: LLZ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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