BoneView
K-Number: K222176 · 2023-03-02
ApplicantGleamer
Decision Date2023-03-02
Product CodeQBS
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
BoneView is a medical device manufactured by Gleamer. It received FDA 510(k) clearance on 2023-03-02 under approval 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. It is manufactured by Gleamer. The 510(k) number is K222176.
When was BoneView approved by the FDA?
BoneView received FDA 510(k) clearance on 2023-03-02, under approval number K222176.
What company makes BoneView?
BoneView is manufactured by Gleamer.
What is the FDA product code for BoneView?
The FDA product code for BoneView is QBS.
Other Devices by Gleamer
Related Devices (Code: QBS)
DEN180005OsteoDetectImagen Technologies, Inc.
K193417FractureDetect (FX)Imagen Technologies, Inc.
K220164RayvolveAzmed Sas
K212365BoneViewGleamer
K223491Critical Care Suite with Pneumothorax Detection AI Algorithm, Critical Care Suite 2.1, Critical Care SuiteGe Medical Systems, LLC
K240712icobrain ariaIcometrix NV
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.