FDA 510(k)

MiPACS V5 (1.0.0)

K-Number: K260231 · 2026-06-25

Decision Date2026-06-25

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

MiPACS V5 (1.0.0) is the device name listed in this FDA 510(k) record. The listed applicant is Apryse Software Corp. It received FDA 510(k) clearance on 2026-06-25 under 510(k) number K260231. 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 V5 (1.0.0)?

MiPACS V5 (1.0.0) is a medical device that received FDA 510(k) clearance on 2026-06-25. The listed applicant is Apryse Software Corp. The 510(k) number is K260231.

When did MiPACS V5 (1.0.0) receive FDA 510(k) clearance?

MiPACS V5 (1.0.0) received FDA 510(k) clearance on 2026-06-25, under 510(k) number K260231.

Who is the listed applicant for MiPACS V5 (1.0.0)?

The FDA 510(k) record lists Apryse Software Corp as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MiPACS V5 (1.0.0)?

The FDA product code for MiPACS V5 (1.0.0) 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.

K262449AdvaViewADVAHEALTH SOLUTIONS, LLC K261916NeuroQuant PETCortechs Labs, Inc.K260936RadioViewAINeurocareai, Inc. (Dba Savelife.Ai)K260588Cleerly LABSCleerly, Inc.K262462TheraSphere 360™ Y-90 Management PlatformBoston Scientific Corporation K262143ImageGrid StreamVueCandelis, Inc.

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.