FDA 510(k)

MiPACS HTML5 Web Viewer

K-Number: K212984 · 2021-11-12

Decision Date2021-11-12

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

MiPACS HTML5 Web Viewer is the device name listed in this FDA 510(k) record. The listed applicant is Lead Technologies, Inc.. It received FDA 510(k) clearance on 2021-11-12 under 510(k) number K212984. 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 MiPACS HTML5 Web Viewer?

MiPACS HTML5 Web Viewer is a medical device that received FDA 510(k) clearance on 2021-11-12. The listed applicant is Lead Technologies, Inc.. The 510(k) number is K212984.

When did MiPACS HTML5 Web Viewer receive FDA 510(k) clearance?

MiPACS HTML5 Web Viewer received FDA 510(k) clearance on 2021-11-12, under 510(k) number K212984.

Who is the listed applicant for MiPACS HTML5 Web Viewer?

The FDA 510(k) record lists Lead Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MiPACS HTML5 Web Viewer?

The FDA product code for MiPACS HTML5 Web Viewer is LLZ.

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.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.