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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Imaging, Optical Coherence Tomography (Oct)
510(k) Number K253101
Device Name HyperVue™ Imaging System - Integrated
Applicant
Spectrawave, Inc.
12 Oak Park Dr.
Bedford,  MA  01730
Applicant Contact Ankit Shah
Correspondent
Spectrawave, Inc.
12 Oak Park Dr.
Bedford,  MA  01730
Correspondent Contact Ankit Shah
Regulation Number892.1560
Classification Product Code
NQQ  
Subsequent Product Code
IYO  
Date Received09/24/2025
Decision Date 12/15/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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