FDA 510(k)

BoneView

K-Number: K222176 · 2023-03-02

Decision Date2023-03-02

Product CodeQBS

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

BoneView is the device name listed in this FDA 510(k) record. The listed applicant is Gleamer. It received FDA 510(k) clearance on 2023-03-02 under 510(k) number K222176. The device is classified under product code QBS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BoneView?

BoneView is a medical device that received FDA 510(k) clearance on 2023-03-02. The listed applicant is Gleamer. The 510(k) number is K222176.

When did BoneView receive FDA 510(k) clearance?

BoneView received FDA 510(k) clearance on 2023-03-02, under 510(k) number K222176.

Who is the listed applicant for BoneView?

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

What is the FDA product code for BoneView?

The FDA product code for BoneView is QBS.

Other records listing Gleamer 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.

K212365BoneView

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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.