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Recognized a 510(k)/PMA number — showing its clearance record and devices.

Clearance record K153343

MAGNETOM Aera, MAGNETOM Skyra, MAGNETOM Prisma, MAGNETOM Prisma fit · Siemens Medi Cal Solutions, Inc. · decided 2016-04-15 (SESE)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
Patient table, mobile 098 1.5T10433197Siemens Healthcare GmbHLNH LNI MOS04056869022628
MAGNETOM Prisma10849583Siemens Healthcare GmbHLNH LNI MOS04056869006734
1.5T Loop 4 cm MR coil10185556Siemens Healthcare GmbHLNH LNI MOS04056869014821
Patient table 021 mobil cpl.10849726Siemens Healthcare GmbHLNH LNI MOS04056869022680
1.5T Loop 7 cm MR coil10185555Siemens Healthcare GmbHLNH LNI MOS04056869014814
Patient table, mobile 098 1.5T10591661Siemens Healthcare GmbHLNH LNI MOS04056869022635
Flex Small 4 MR coil 1.5T10185553Siemens Healthcare GmbHLNH LNI MOS04056869014791
MAGNETOM Aera10432914Siemens Healthcare GmbHLNH LNI MOS04056869006697
Patient table mobile S103 1.5T cpl.10849625Siemens Healthcare GmbHLNH LNI MOS04056869022840
Flex large 4 MR coil set 1.5T10185502Siemens Healthcare GmbHLNH LNI MOS04056869014616
Flex Large 4 MR coil 3T08625761Siemens Healthcare GmbHLNH LNI MOS OUO04056869014388
Head/Neck 20 MR coil set 1.5T 09810185541Siemens Healthcare GmbHLNH LNI MOS04056869014708
Body 6 long MR Coil Set 1.5T10839371Siemens Shenzhen Magnetic Resonance Ltd.LNH LNI MOS04056869015583
PA 36 MR Coil 1.5T10496542Siemens Healthcare GmbHLNH LNI MOS04056869014906
Flex small 4 MR coil set 3T08626876Siemens Healthcare GmbHLNH OUO04056869014524
1.5T Loop 4 cm MR coil kit10185506Siemens Healthcare GmbHLNH LNI MOS04056869014654
CP Extremity MR coil set 09810606592Siemens Healthcare GmbHLNH LNI MOS04056869015163
Body 18 long MR coil 3T10835253Siemens Healthcare GmbHLNH LNI MOS04056869015392
Body 30 MR coil 1.5T10835444Siemens Healthcare GmbHLNH LNI MOS04056869015453
Body 18 MR Coil set 1.5T 09810185539Siemens Healthcare GmbHLNH LNI MOS04056869014685
MAGNETOM Prisma10849582Siemens Healthcare GmbHLNH LNI MOS04056869006727
Body 18 MR Coil 3T10835325Siemens Healthcare GmbHLNH LNI MOS04056869015415
CP Extremity MR Coil10496660Siemens Healthcare GmbHLNH LNI MOS04056869014944
Body 18 MR Coil 1.5T10496530Siemens Healthcare GmbHLNH LNI MOS04056869014883
PA 36 MR coil set 1.5T 09810185542Siemens Healthcare GmbHLNH LNI MOS04056869014715