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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cabinet, X-Ray System
510(k) Number K213691
Device Name Solas OR
Applicant
Cirdan Imaging, Ltd.
The Green, Tullynacross Rd., Lambeg
Lisburn,  GB BT27 5SR
Applicant Contact Paul Matthews
Correspondent
Regulatory Technology Services, LLC
1000 Westgate Dr. Suite #510k
Saint Paul,  MN  55114
Correspondent Contact Prithul Bom
Regulation Number892.1680
Classification Product Code
MWP  
Date Received11/23/2021
Decision Date 12/22/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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