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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K260009
Device Name LungPoint Virtual Bronchoscopic Navigation (VBN) Software
Applicant
Broncus Medical, Inc.
125 Nicholson Ln.
San Jose,  CA  95134
Applicant Contact Clay Antoinette
Correspondent
Broncus Medical, Inc.
125 Nicholson Ln.
San Jose,  CA  95134
Correspondent Contact Antoinette Clay
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received01/02/2026
Decision Date 04/24/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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