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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Tomography, Computed, Emission
510(k) Number K982044
Device Name NUCAMMA R+
Applicant
Is2 Research, Inc.
20 Gurdwara Rd., Bays 3-6
Nepean, Ontario,  CA K2E 8B3
Applicant Contact PETER SCHULTZ
Correspondent
Is2 Research, Inc.
20 Gurdwara Rd., Bays 3-6
Nepean, Ontario,  CA K2E 8B3
Correspondent Contact PETER SCHULTZ
Regulation Number892.1200
Classification Product Code
KPS  
Date Received06/10/1998
Decision Date 09/02/1998
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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