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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Nuclear Magnetic Resonance Imaging
510(k) Number K020268
Device Name ISAAC 1.5 T MR SYSTEM
Applicant
Chi, Inc.
C/O C.L. Mcintosh
12300 Twinbrook Pkwy.
Rockville,  MD  20852
Applicant Contact T. WHIT ATHEY
Correspondent
Chi, Inc.
C/O C.L. Mcintosh
12300 Twinbrook Pkwy.
Rockville,  MD  20852
Correspondent Contact T. WHIT ATHEY
Regulation Number892.1000
Classification Product Code
LNH  
Date Received01/25/2002
Decision Date 04/25/2002
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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