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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Stationary
510(k) Number K214012
Device Name Straight Arm DDR
Applicant
Konica Minolta Healthcare Americas, Inc.
2217 Us Hwy. 70 E.
Garner,  NC  27529
Applicant Contact Jan Maniscalco
Correspondent
Konica Minolta Healthcare Americas, Inc.
2217 Us Hwy. 70 E.
Garner,  NC  27529
Correspondent Contact Jan Maniscalco
Regulation Number892.1680
Classification Product Code
KPR  
Subsequent Product Code
MQB  
Date Received12/22/2021
Decision Date 01/12/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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