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FDA 510(k)

JiveX (Model Number / Release: 5.3)

K-Number: K212321 · 2021-09-23

ApplicantVisus Health IT GmbH
Decision Date2021-09-23
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

JiveX (Model Number / Release: 5.3) is the device name listed in this FDA 510(k) record. The listed applicant is Visus Health IT GmbH. It received FDA 510(k) clearance on 2021-09-23 under 510(k) number K212321. 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 JiveX (Model Number / Release: 5.3)?

JiveX (Model Number / Release: 5.3) is a medical device that received FDA 510(k) clearance on 2021-09-23. The listed applicant is Visus Health IT GmbH. The 510(k) number is K212321.

When did JiveX (Model Number / Release: 5.3) receive FDA 510(k) clearance?

JiveX (Model Number / Release: 5.3) received FDA 510(k) clearance on 2021-09-23, under 510(k) number K212321.

Who is the listed applicant for JiveX (Model Number / Release: 5.3)?

The FDA 510(k) record lists Visus Health IT GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for JiveX (Model Number / Release: 5.3)?

The FDA product code for JiveX (Model Number / Release: 5.3) is LLZ.

Other records listing Visus Health IT GmbH 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.

K231041JiveX (Model Number / Release: 5.4)K200703JiveXK181964JiveX

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, LLCK261916NeuroQuant PETCortechs Labs, Inc.K260936RadioViewAINeurocareai, Inc. (Dba Savelife.Ai)K260588Cleerly LABSCleerly, Inc.K262462TheraSphere 360™ Y-90 Management PlatformBoston Scientific CorporationK262143ImageGrid 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.

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