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FDA 510(k)

Shield System (Siemens 30x40)

K-Number: K260607 · 2026-07-31

ApplicantRadiaction , Ltd.
Decision Date2026-07-31
Product CodeOWB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Shield System (Siemens 30x40) is the device name listed in this FDA 510(k) record. The listed applicant is Radiaction , Ltd.. It received FDA 510(k) clearance on 2026-07-31 under 510(k) number K260607. 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 (Siemens 30x40)?

Shield System (Siemens 30x40) is a medical device that received FDA 510(k) clearance on 2026-07-31. The listed applicant is Radiaction , Ltd.. The 510(k) number is K260607.

When did Shield System (Siemens 30x40) receive FDA 510(k) clearance?

Shield System (Siemens 30x40) received FDA 510(k) clearance on 2026-07-31, under 510(k) number K260607.

Who is the listed applicant for Shield System (Siemens 30x40)?

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 (Siemens 30x40)?

The FDA product code for Shield System (Siemens 30x40) 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.

K222625Shield SystemK212159Shield System

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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