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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Display, Diagnostic Radiology
510(k) Number K200889
Device Name iMac 27 & PL 4.0
Applicant
Quantum-Spectra, LLC
1621 Central Ave. Wyoming Agent
Wilmington,  DE  19809
Applicant Contact Marc Leppla
Correspondent
Quantum Spectra, LLC
501, Silverside Rd. St. 105
Wilmington,  DE  19809
Correspondent Contact Marc Leppla
Regulation Number892.2050
Classification Product Code
PGY  
Date Received04/03/2020
Decision Date 06/02/2020
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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