3T HD BREAST 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 3t Hd Breast Array.

Pre-market Notification Details

Device IDK052585
510k NumberK052585
Device Name:3T HD BREAST ARRAY
ClassificationCoil, Magnetic Resonance, Specialty
Applicant USA INSTRUMENTS, INC. 1515 DANNER DR. Aurora,  OH  44202
ContactDavid Brown
CorrespondentDavid Brown
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 Date2005-10-04
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00840682103763 K052585 000
00840682103756 K052585 000

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