1.5T 12 CHANNEL BODY ARRAY

Coil, Magnetic Resonance, Specialty

USA INSTRUMENTS, INC.

The following data is part of a premarket notification filed by Usa Instruments, Inc. with the FDA for 1.5t 12 Channel Body Array.

Pre-market Notification Details

Device IDK052584
510k NumberK052584
Device Name:1.5T 12 CHANNEL BODY ARRAY
ClassificationCoil, Magnetic Resonance, Specialty
Applicant USA INSTRUMENTS, INC. 1515 DANNER DR. Aurora,  OH  44202
ContactRobert B Smith
CorrespondentRobert B Smith
USA INSTRUMENTS, INC. 1515 DANNER DR. Aurora,  OH  44202
Product CodeMOS  
CFR Regulation Number892.1000 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-09-20
Decision Date2005-10-07
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00840682117777 K052584 000
00840682117746 K052584 000
00840682117739 K052584 000

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