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U.S. Department of Health and Human Services

510(k) Premarket Notification

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11 to 20 of 54 Results
ProductCode: LNH Applicant: HITACHI MEDICAL SYSTEMS AMERICA, INC. Decision Date To: 05/22/2022
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airis elite magnetic resonance imaging device HITACHI MEDICAL SYSTEMS AMERICA, INC. K032232 09/29/2003
hitachi altaire HITACHI MEDICAL SYSTEMS AMERICA, INC. K022390 10/11/2002
hitachi airis ii HITACHI MEDICAL SYSTEMS AMERICA, INC. K001334 07/06/2000
hitachi altaire HITACHI MEDICAL SYSTEMS AMERICA, INC. K002420 10/17/2000
airis ii magnetic resonance diagnostic device,interventional mr package HITACHI MEDICAL SYSTEMS AMERICA, INC. K984280 02/08/1999
magnetic resonance diagnostic device, version 5.0 operating system software HITACHI MEDICAL SYSTEMS AMERICA, INC. K984274 01/25/1999
airis ii HITACHI MEDICAL SYSTEMS AMERICA, INC. K974212 02/09/1998
stratis ii HITACHI MEDICAL SYSTEMS AMERICA, INC. K974498 02/26/1998
version 4 operating system software HITACHI MEDICAL SYSTEMS AMERICA, INC. K971279 07/03/1997
1w/kg sar(part of version 6-05 operating system software) HITACHI MEDICAL SYSTEMS AMERICA, INC. K962048 08/14/1996
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