FDA 510(k)

Helianthus

K-Number: K202822 · 2021-12-15

Decision Date2021-12-15

Product CodeMUE

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Helianthus is the device name listed in this FDA 510(k) record. The listed applicant is Metaltronica Spa. It received FDA 510(k) clearance on 2021-12-15 under 510(k) number K202822. The device is classified under product code MUE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Helianthus?

Helianthus is a medical device that received FDA 510(k) clearance on 2021-12-15. The listed applicant is Metaltronica Spa. The 510(k) number is K202822.

When did Helianthus receive FDA 510(k) clearance?

Helianthus received FDA 510(k) clearance on 2021-12-15, under 510(k) number K202822.

Who is the listed applicant for Helianthus?

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

What is the FDA product code for Helianthus?

The FDA product code for Helianthus is MUE.

Related Devices (Code: MUE)

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.

K253678MAMMOMAT B.brilliant (11372950)Siemens Medical Solutions USA, Inc.K254092Bellalun 2D (VDMS-1000S)Vieworks Co., Ltd.K260087Senographe Pristina; SenoBright HD; Pristina Serena; Pristina Serena BrightGE Medical Systems SCS K243420HESTIAGenoray Co., Ltd.K2438492430TCA with Xmaru WRayence Co., Ltd.K241113VIVIX-MVieworks Co., Ltd.

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.