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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Imaging, Pulsed Doppler, Ultrasonic
510(k) Number K001711
Device Name M2410B IMAGEPOINT HX MULTISPECIALTY SYSTEM, VERSION B.1
Applicant
Agilent Technologies, Inc.
3000 Minuteman Rd.
Andover,  MA  01810
Applicant Contact STEVE SINGLAR
Correspondent
Tuv Product Service, Inc.
1775 Old Hwy. 8
New Brighton,  MN  55112
Regulation Number892.1550
Classification Product Code
IYN  
Date Received06/05/2000
Decision Date 06/20/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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