AUTOTUNE DEVICE (ATD II)/PHILIPS S-15/ACS MRI SCAN

System, Nuclear Magnetic Resonance Imaging

MEDRAD, INC.

The following data is part of a premarket notification filed by Medrad, Inc. with the FDA for Autotune Device (atd Ii)/philips S-15/acs Mri Scan.

Pre-market Notification Details

Device IDK932403
510k NumberK932403
Device Name:AUTOTUNE DEVICE (ATD II)/PHILIPS S-15/ACS MRI SCAN
ClassificationSystem, Nuclear Magnetic Resonance Imaging
Applicant MEDRAD, INC. RTE.910 MEDRAD DRIVE, P.O. BOX 780 Indianola,  PA  15051
ContactJohn E Stevens
CorrespondentJohn E Stevens
MEDRAD, INC. RTE.910 MEDRAD DRIVE, P.O. BOX 780 Indianola,  PA  15051
Product CodeLNH  
CFR Regulation Number892.1000 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-05-03
Decision Date1994-02-24

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