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FDA 510(k)

ROSA Knee System with UltraSound Imaging Platform (USIP)

K-Number: K252058 · 2026-02-06

ApplicantBalmoral Medical, LLC
Decision Date2026-02-06
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

ROSA Knee System with UltraSound Imaging Platform (USIP) is a medical device manufactured by Balmoral Medical, LLC. It received FDA 510(k) clearance on 2026-02-06 under approval number K252058. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ROSA Knee System with UltraSound Imaging Platform (USIP)?

ROSA Knee System with UltraSound Imaging Platform (USIP) is a medical device that received FDA 510(k) clearance on 2026-02-06. It is manufactured by Balmoral Medical, LLC. The 510(k) number is K252058.

When was ROSA Knee System with UltraSound Imaging Platform (USIP) approved by the FDA?

ROSA Knee System with UltraSound Imaging Platform (USIP) received FDA 510(k) clearance on 2026-02-06, under approval number K252058.

What company makes ROSA Knee System with UltraSound Imaging Platform (USIP)?

ROSA Knee System with UltraSound Imaging Platform (USIP) is manufactured by Balmoral Medical, LLC.

What is the FDA product code for ROSA Knee System with UltraSound Imaging Platform (USIP)?

The FDA product code for ROSA Knee System with UltraSound Imaging Platform (USIP) is OLO.

Related Clinical Trials

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Related PubMed Literature

PMID: 42204020 A Minimal UDI-DICOM Mapping Profile and Validation Artifact for Medical-Device Imaging Workflows. Journal of imaging informatics in medicine (2026) PMID: 41987469 [Progress and Prospects of Ultrasound Brain-Computer Interface Medical Devices Technology]. Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation (2026) PMID: 41887630 Capacity building for ethical use of artificial intelligence in health: protocol for a scoping review of training initiatives and gaps in Africa. BMJ open (2026) PMID: 41762851 A biomimetic nanoplatform boosting efferocytosis via dual-pathway regulation for atherosclerosis therapy and imaging. Biomaterials (2026)

Related Devices (Code: OLO)

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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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