Medical Device Manufacturer · US , Danvers , MA

Siemens Medical Solutions - FDA 510(k) Cleared Devices

15 submissions · 15 cleared · Since 2003

Recent clearances: YSIO X.pree, LUMINOS Q.namix T, YSIO X.pree

15

Total

15

Cleared

0

Denied

FDA 510(k) Regulatory Record - Siemens Medical Solutions Radiology ✕

14 devices

1-14 of 14

Cleared Jul 31, 2025

Radiology · 142d

Cleared Jul 14, 2025

LUMINOS Q.namix T

Radiology · 131d

Cleared May 21, 2024

Radiology · 200d

Cleared Nov 29, 2023

MULTIX Impact E

Radiology · 27d

Cleared Jul 25, 2023

MOBILETT Impact

Radiology · 55d

Cleared Nov 17, 2022

Radiology · 198d

Cleared Feb 18, 2022

Multitom Rax with True2scale Body Scan Option

Radiology · 218d

Cleared Aug 16, 2010

SYNGO TRUED SOFTWARE

Radiology · 55d

Cleared Apr 25, 2008

SYNGO DYNAMICS VERSION 7.0

Radiology · 15d

Cleared Jun 26, 2007

INSPACE 4D SOFTWARE PACKAGE WITH EXTENDED FUNCTIONALITY

Radiology · 22d

Cleared Mar 26, 2007

FLEX AND LOOP COIL SET 1.5 T

Radiology · 19d

Cleared Jun 29, 2006

SYNGO TRUED, MODEL VC10A

Radiology · 15d

Cleared Apr 28, 2006

SYNGO US WORKPLACE

Radiology · 17d

Cleared Dec 09, 2004

MAGNETOM C! MR SYSTEM

Radiology · 36d