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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 K212012
Device Name Follicle Clarity
Applicant
Cycle Clarity
1209 Fifteen Mile Landing Rd.
Awendaw,  SC  29429
Applicant Contact John Schnorr
Correspondent
Cycle Clarity
1209 Fifteen Mile Landing Rd.
Awendaw,  SC  29429
Correspondent Contact John Schnorr
Regulation Number892.2050
Classification Product Code
QIH  
Date Received06/28/2021
Decision Date 01/19/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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