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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, tomography, computed, emission
510(k) Number K212004
Device Name MyoSPECT, MyoSpect ES
Applicant
GE Healthcare
4 Hayozma Street
Tirat Hacarmel,  IL 30200
Applicant Contact George Mashour
Correspondent
GE Healthcare
4 Hayozma Street
Tirat Hacarmel,  IL 30200
Correspondent Contact George Mashour
Regulation Number892.1200
Classification Product Code
KPS  
Date Received06/28/2021
Decision Date 08/27/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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