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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transducer, Ultrasonic, Diagnostic
510(k) Number K860568
Device Name ULTRASONIC IMAGING SYSTEM (MODIFIED)
Applicant
Interspec, Inc.
1100 E. Hector St.
Conshohocken,  PA  19428
Applicant Contact BERNARDI PHD
Correspondent
Interspec, Inc.
1100 E. Hector St.
Conshohocken,  PA  19428
Correspondent Contact BERNARDI PHD
Regulation Number892.1570
Classification Product Code
ITX  
Date Received02/14/1986
Decision Date 08/11/1986
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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