FDA 510(k) Applications Submitted by NADIA SOOKDEO
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K120315 |
02/01/2012 |
SYNGO.MR SPECTRO ENGINE, SYNGO.MR SPECTRO SVS, SYNGO.MR SPECTRO CSI, SYNGO.MR SPECTRO EXTENSION |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
| K130262 |
02/01/2013 |
MAGNETOM ESSENZA WITH SYNGO MR D14 |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
| K130749 |
03/19/2013 |
SYNGO.MR GENERAL; SYNGO.MR CARDIOLOGY; SYNGO.MR VASCULAR |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
| K121160 |
04/16/2012 |
MAGNETOM SPECTRA |
SIEMENS MEDICAL SOLUTIONS USA INC. |
| K111861 |
06/30/2011 |
SYNGO.MR ONCO, SYNGO.MR 3D LESION SEGMENTATION, SYNGO.MR ONCO ENGINE |
SIEMENS MEDICAL SYSTEMS USA |
| K132119 |
07/09/2013 |
MAGNETOM PRISMA, MAGNETOM PRISMA FIT |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
| K141977 |
07/21/2014 |
MAGNETOM AERA WITH SOFTWARE SYNGO MR E11A, MAGNETOM SKYRA WITH SOFTWARE SYNGO MR E11A, MAGNETOM SKYRA WITH 24 RF CHANNEL |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
| K132831 |
09/10/2013 |
QUIET/SILENT SCANNING SUITE |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
| K132951 |
09/19/2013 |
MAGNETOM AERA |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
| K133226 |
10/21/2013 |
BIOGRAPH MMR |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
| K133401 |
11/06/2013 |
SYNO MR NEUROLOGY, SYNGO MR ONCOLOGY, SYNGO. MR BREVIS, SYNGO MMR GENERAL |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
| K133435 |
11/08/2013 |
MAGNETOM AERA AND SKYRA WITH SOFTWARE MR D13A |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
| K123510 |
11/13/2012 |
MAGNETOM SKYRA |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
| K123938 |
12/20/2012 |
SYNGO MR B19 FOR MAGNETOM AVANTO, SYNGO MR B19 FOR MAGNETOM ESPREE, SYNGO MR B19 FOR MAGNETOM SYMPHONY A TIM SYSTEM, SYN |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
| K160627 |
03/07/2016 |
Symphony Patient Transport System, Symphony Patient Trolley, Symphony Standard Transfer Surface, Symphony Portrait (Head/Neck) Transfer Surface, Symphony Brachytherapy solution |
QFIX |
| K152321 |
08/17/2015 |
kVue Encompass SRS Insert (Encompass Insert), Encompass SRS Standalone (Encompass Device), Encompass SRS MRI Immobilization device (Encompass MRI Device, Encompass Intracranial Fibreplast Variable Perf Head Only Open View System, Encompass Intracranial Fi |
QFIX |
|
|
