ULTRASONIC IMAGING SYSTEM (MODIFIED)

Transducer, Ultrasonic, Diagnostic

INTERSPEC, INC.

The following data is part of a premarket notification filed by Interspec, Inc. with the FDA for Ultrasonic Imaging System (modified).

Pre-market Notification Details

Device IDK860568
510k NumberK860568
Device Name:ULTRASONIC IMAGING SYSTEM (MODIFIED)
ClassificationTransducer, Ultrasonic, Diagnostic
Applicant INTERSPEC, INC. 1100 E. HECTOR ST. Conshohocken,  PA  19428
ContactBernardi Phd
CorrespondentBernardi Phd
INTERSPEC, INC. 1100 E. HECTOR ST. Conshohocken,  PA  19428
Product CodeITX  
CFR Regulation Number892.1570 [🔎]
DecisionSubstantially Equivalent For Some Indications (SN)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-02-14
Decision Date1986-08-11

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