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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, Pulsed Echo, Ultrasonic
510(k) Number K160792
Device Name Morpheus RealTime Ultrasound, Pathway RealTime Ultrasound, QuickScan Bladder Ultrasound
Applicant
The Prometheus Group
1 Washington St.
Suite 303
Dover,  NH  03820
Applicant Contact Joshua Bird
Correspondent
The Prometheus Group
1 Washington St.
Suite 303
Dover,  NH  03820
Correspondent Contact Joshua Bird
Regulation Number892.1560
Classification Product Code
IYO  
Subsequent Product Code
ITX  
Date Received03/23/2016
Decision Date 04/15/2016
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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