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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name System, Digital Image Communications, Radiological
510(k) Number K952484
Device Name MODEM TRANSFER APPLICATION SOFTWARE NSMD-001A & NSMD-070A
Applicant
Toshiba America Medical Systems, In.C
2441 Michelle Dr.
P.O. Box 2068
Tustin,  CA  92781
Applicant Contact JAVAD SEYEDZADEH
Correspondent
Toshiba America Medical Systems, In.C
2441 Michelle Dr.
P.O. Box 2068
Tustin,  CA  92781
Correspondent Contact JAVAD SEYEDZADEH
Regulation Number892.2020
Classification Product Code
LMD  
Date Received05/30/1995
Decision Date 06/23/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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