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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, Tomography, Computed
510(k) Number K131433
FOIA Releasable 510(k) K131433
Device Name ISYS 1 (U.S),ACCESSORY, NON-STERILE
Applicant
Isys Medizintechnik GmbH
56 Westcott Rd.
Stamford,  CT  06902
Applicant Contact CORNELIA DAMSKY
Correspondent
Isys Medizintechnik GmbH
56 Westcott Rd.
Stamford,  CT  06902
Correspondent Contact CORNELIA DAMSKY
Regulation Number892.1750
Classification Product Code
JAK  
Date Received05/17/2013
Decision Date 03/11/2014
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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