FDA 510(k)

Shield System

K-Number: K212159 · 2022-03-30

Decision Date2022-03-30

Product CodeOWB

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Shield System is the device name listed in this FDA 510(k) record. The listed applicant is Radiaction , Ltd.. It received FDA 510(k) clearance on 2022-03-30 under 510(k) number K212159. The device is classified under product code OWB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Shield System?

Shield System is a medical device that received FDA 510(k) clearance on 2022-03-30. The listed applicant is Radiaction , Ltd.. The 510(k) number is K212159.

When did Shield System receive FDA 510(k) clearance?

Shield System received FDA 510(k) clearance on 2022-03-30, under 510(k) number K212159.

Who is the listed applicant for Shield System?

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

What is the FDA product code for Shield System?

The FDA product code for Shield System is OWB.

Other records listing Radiaction , Ltd. 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.

K260607Shield System (Siemens 30x40)K222625Shield System

Related Devices (Code: OWB)

K254205Zenition 30Philips Medical Systems Nederland B.V.K260607Shield System (Siemens 30x40)Radiaction , Ltd.K253670SmartCT (R3.0 (L10))Philips Medical Systems B.V.K252735C-beamPulmera, Inc.K252503Intelligent NRCanon, Inc.K254173ARTIS icono floor; ARTIS icono biplane; ARTIS icono ceiling; ARTIS phenoSiemens Medical Solutions USA, 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.