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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Automated Radiological Image Processing Software
510(k) Number K241280
Device Name Constellation (CON-001)
Applicant
Q Bio, Inc.
1411 Industrial Rd.
San Carlos,  CA  94070
Applicant Contact Clarissa Shen
Correspondent
Q Bio, Inc.
1411 Industrial Rd.
San Carlos,  CA  94070
Correspondent Contact M. Jason Brooke
Regulation Number892.2050
Classification Product Code
QIH  
Subsequent Product Code
LLZ  
Date Received05/07/2024
Decision Date 09/12/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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