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FDA 510(k)

CLISIS SYSTEMS, Discovery RF180

K-Number: K213081 · 2021-10-26

ApplicantGeneral Medical Merate S.P.A
Decision Date2021-10-26
Product CodeIZF
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CLISIS SYSTEMS, Discovery RF180 is the device name listed in this FDA 510(k) record. The listed applicant is General Medical Merate S.P.A. It received FDA 510(k) clearance on 2021-10-26 under 510(k) number K213081. The device is classified under product code IZF. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CLISIS SYSTEMS, Discovery RF180?

CLISIS SYSTEMS, Discovery RF180 is a medical device that received FDA 510(k) clearance on 2021-10-26. The listed applicant is General Medical Merate S.P.A. The 510(k) number is K213081.

When did CLISIS SYSTEMS, Discovery RF180 receive FDA 510(k) clearance?

CLISIS SYSTEMS, Discovery RF180 received FDA 510(k) clearance on 2021-10-26, under 510(k) number K213081.

Who is the listed applicant for CLISIS SYSTEMS, Discovery RF180?

The FDA 510(k) record lists General Medical Merate S.P.A as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CLISIS SYSTEMS, Discovery RF180?

The FDA product code for CLISIS SYSTEMS, Discovery RF180 is IZF.

Other records listing General Medical Merate S.P.A 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.

K173395MECALL CLISIS SYSTEMS, Discovery RF180

Related Devices (Code: IZF)

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.

K252649TAP2DNano-X Imaging , Ltd.K252133Adaptix Ortho350Adaptix LimitedK250850Nanox.ARC XNano-X Imaging , Ltd.K242395Nanox.ARCNano-X Imaging , Ltd.K222934Nanox.ARCNano-X Imaging , Ltd.K221949Ortho Device, ADAPTIX 3D Orthopedic Imaging SystemPausch Medical GmbH

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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