ClearanceBrief
Company ยท US

Siemens Medical Solutions USA, Inc.

FDA 510(k) clearances and medical device recalls filed under this name, 1980 to 2026. Name variants (Inc, Corp, punctuation) are merged.

834510(k) clearances (15 in 12 months)
1,245recalls (19 in 12 months)
1,199recalls that name a 510(k)

Product codes

CodeDeviceRecords
JAKSystem, X-Ray, Tomography, Computed279
OWBInterventional Fluoroscopic X-Ray System258
IYEAccelerator, Linear, Medical224
LNHSystem, Nuclear Magnetic Resonance Imaging197
LLZSystem, Image Processing, Radiological184
KPSSystem, Tomography, Computed, Emission183
IYNSystem, Imaging, Pulsed Doppler, Ultrasonic137
IZISystem, X-Ray, Angiographic111
KPRSystem, X-Ray, Stationary48
IYOSystem, Imaging, Pulsed Echo, Ultrasonic42
JAASystem, X-Ray, Fluoroscopic, Image-Intensified39
DQKComputer, Diagnostic, Programmable30
DSIDetector And Alarm, Arrhythmia27
IZLSystem, X-Ray, Mobile24
MUEFull Field Digital, System, X-Ray, Mammographic19
MUJSystem, Planning, Radiation Therapy Treatment19
MQBSolid State X-Ray Imager (Flat Panel/Digital Imager)17
QIHAutomated Radiological Image Processing Software14
MHXMonitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)13
OBJCatheter, Ultrasound, Intravascular13

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Sep 25, 2026K260055syngo.CT Brain Quantification
Siemens Medical Solutions USA, Inc.
QIH
Sep 10, 2026K261696ACUNAV Luxera 4D ICE Catheter
Siemens Medical Solutions USA, Inc.
OBJ
Aug 31, 2026K260488MULTIX Impact; MULTIX Impact C
Siemens Medical Solutions USA, Inc.
KPR
Jun 25, 2026K253786syngo.CT Coronary Cockpit
Siemens Medical Solutions USA, Inc.
QIH
Jun 18, 2026K253678MAMMOMAT B.brilliant (11372950)
Siemens Medical Solutions USA, Inc.
MUE
Jun 16, 2026K260844ACUSON Sequoia Diagnostic Ultrasound System;ACUSON Sequoia Select Diagnostic Ultrasound System;ACUSON Origin Diagnostic
Siemens Medical Solutions USA, Inc.
IYN
May 21, 2026K261315Symbia Pro.specta Q3 (11364751);Symbia Pro.specta X3 (11364752);Symbia Pro.specta X7 (11364753);Symbia Pro.specta VA40 F
Siemens Medical Solutions USA, Inc.
KPS
Apr 29, 2026K254184syngo Application Software
Siemens Medical Solutions USA, Inc.
QIH
Apr 24, 2026K254173ARTIS icono floor; ARTIS icono biplane; ARTIS icono ceiling; ARTIS pheno
Siemens Medical Solutions USA, Inc.
OWB
Apr 23, 2026K253752ARTIS genio floor; ARTIS icono.explore floor
Siemens Medical Solutions USA, Inc.
OWB
Mar 20, 2026K253574SOMATOM X.cite; SOMATOM X.ceed
Siemens Medical Solutions USA, Inc.
JAK
Feb 10, 2026K254016MI View&GO
Siemens Medical Solutions USA, Inc.
QIH
Nov 17, 2025K253487ACUSON Maple Diagnostic Ultrasound System; ACUSON Maple Select Diagnostic Ultrasound System
Siemens Medical Solutions USA, Inc.
IYN
Nov 13, 2025K253457ACUSON Juniper Diagnostic Ultrasound System; ACUSON Juniper Select Diagnostic Ultrasound System
Siemens Medical Solutions USA, Inc.
IYN
Nov 4, 2025K250241Cios Select
Siemens Medical Solutions USA, Inc.
OWB
Oct 15, 2025K251805syngo.CT Dual Energy
Siemens Medical Solutions USA, Inc.
JAK
Aug 20, 2025K251481ACUSON Sequoia Diagnostic Ultrasound System; ACUSON Sequoia Select Diagnostic Ultrasound System; ACUSON Origin Diagnosti
Siemens Medical Solutions USA, Inc.
IYN
Jul 31, 2025K251561Biograph Trinion
Siemens Medical Solutions USA, Inc.
KPS
Jul 31, 2025K250738YSIO X.pree
Siemens Medical Solutions
KPR
Jul 29, 2025K251523Cios Spin
Siemens Medical Solutions USA, Inc.
OWB
Jul 28, 2025K251061NAEOTOM Alpha.Peak/NAEOTOM Alpha; NAEOTOM Alpha.Pro; NAEOTOM Alpha.Prime
Siemens Medical Solutions USA, Inc.
JAK
Jul 14, 2025K250660LUMINOS Q.namix T; LUMINOS Q.namix R
Siemens Medical Solutions
OWB
Jul 9, 2025K251520Cios Alpha; Cios Flow
Siemens Medical Solutions USA, Inc.
OWB
Jul 3, 2025K251671Biograph Vision PET/CT Systems; Biograph mCT PET/CT Systems
Siemens Medical Solutions USA, Inc.
KPS
Jul 3, 2025K251528syngo.via MI Workflows; Scenium; syngo MBF
Siemens Medical Solutions USA, Inc.
QIH
Jul 3, 2025K250822SOMATOM go.Now; SOMATOM go.Up; SOMATOM go.All; SOMATOM go.Top; SOMATOM go.Sim; SOMATOM go.Open Pro; SOMATOM Pro.Pulse
Siemens Medical Solutions USA, Inc.
JAK
Apr 10, 2025K243145syngo.CT LVO Detection
Siemens Medical Solutions USA, Inc.
QAS
Feb 12, 2025K243523NAEOTOM Alpha.Peak/ NAEOTOM Alpha; NAEOTOM Alpha.Pro; NAEOTOM Alpha.Prime
Siemens Medical Solutions USA, Inc.
JAK
Jan 3, 2025K241757syngo.CT Dual Energy
Siemens Medical Solutions USA, Inc.
JAK
Nov 19, 2024K242523ACUSON Sequoia Diagnostic Ultrasound System; ACUSON Sequoia Select Diagnostic Ultrasound System; ACUSON Origin Diagnosti
Siemens Medical Solutions USA, Inc.
IYN
Nov 15, 2024K243299ACUSON Redwood Diagnostic Ultrasound System
Siemens Medical Solutions USA, Inc.
IYN
Oct 30, 2024K243186Symbia Pro.specta Q3 (11364751); Symbia Pro.specta X3 (11364752); Symbia Pro.specta X7 (11364753); Symbia Pro.specta VA3
Siemens Medical Solutions USA, Inc.
KPS
Oct 22, 2024K241572ARTIS icono (VE40A) (floor); ARTIS icono (VE40A) (biplane); ARTIS icono (VE40A) (ceiling); ARTIS pheno (VE40A)
Siemens Medical Solutions USA, Inc.
OWB
Oct 11, 2024K241569syngo Application Software
Siemens Medical Solutions USA, Inc.
LLZ
Sep 3, 2024K241295SOMATOM On.site
Siemens Medical Solutions USA, Inc.
JAK
Aug 30, 2024K242300MI View&GO
Siemens Medical Solutions USA, Inc.
QIH
Aug 30, 2024K242275syngo.via MI Workflows; Scenium; syngo MBF
Siemens Medical Solutions USA, Inc.
QIH
Jul 22, 2024K240704ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound System, ACUSON Origin Diagnosti
Siemens Medical Solutions USA, Inc.
IYN
Jun 12, 2024K233613ACUSON SC2000 Diagnostic Ultrasound System
Siemens Medical Solutions USA, Inc.
IYO
Jun 12, 2024K233610ACUSON P500 Ultrasound System; ACUSON P500 ICE Ultrasound System
Siemens Medical Solutions USA, Inc.
IYN
May 21, 2024K233543YSIO X.pree
Siemens Medical Solutions
KPR
Apr 26, 2024K232799syngo.via RT Image Suite
Siemens Medical Solutions USA, Inc.
MUJ
Apr 3, 2024K232899AI-Rad Companion Organs RT
Siemens Medical Solutions U.S.A.
QKB
Mar 29, 2024K240608MAGNETOM Viato.Mobile
Siemens Medical Solutions USA, Inc.
LNH
Mar 28, 2024K233657NAEOTOM Alpha
Siemens Medical Solutions USA, Inc.
JAK
Mar 27, 2024K233539MAMMOMAT B.brilliant
Siemens Medical Solutions USA, Inc.
MUE
Mar 26, 2024K233650SOMATOM go.Up; SOMATOM go.Now; SOMATOM go.All; SOMATOM go.Top; SOMATOM go.Sim; SOMATOM go.Open Pro; SOMATOM X.cite; SOMA
Siemens Medical Solutions USA, Inc.
JAK
Mar 22, 2024K232431syngo.CT Brain Hemorrhage
Siemens Medical Solutions USA, Inc.
QAS
Mar 22, 2024K232322MAGNETOM Terra; MAGNETOM Terra.X
Siemens Medical Solutions USA, Inc.
LNH
Mar 15, 2024K233748CIARTIC Move (VB10)
Siemens Medical Solutions USA, Inc.
OWB

Newest 50 of 834.

Latest recalls

DateFirm and productCodeLinked 510(k)
Jul 1, 2026Siemens Medical Solutions USA, Inc
ARTIS icono ceiling. Model Number: 11328100.
Open, Classified		 OWBK221516
Jul 1, 2026Siemens Medical Solutions USA, Inc
ARTIS icono floor. Model Number: 11327700.
Open, Classified		 OWBK241572
Jul 1, 2026Siemens Medical Solutions USA, Inc
ARTIS icono ceiling. Model Number: 11328100.
Open, Classified		 OWBK241572
Jul 1, 2026Siemens Medical Solutions USA, Inc
ARTIS icono biplane. Model Number: 11327600.
Open, Classified		 OWBK241572
Jun 4, 2026Siemens Medical Solutions USA, Inc
ARTIS Icono biplane, floor and ceiling.: ARTIS icono biplane Model 11327600. ARTIS icono ceiling Model 11328100. ARTIS icono floor Model 11327700. interventional fluoroscopic x-ray system
Open, Classified		 OWBK241572
Jun 4, 2026Siemens Medical Solutions USA, Inc
ARTIS pheno, Model 10849000. interventional fluoroscopic x-ray system
Open, Classified		 OWBK241572
Apr 16, 2026Siemens Medical Solutions USA, Inc
ARTIS Pheno VE30A and VE40A, Model 10849000
Open, Classified		 OWBK230949
K241572
Apr 7, 2026Siemens Medical Solutions USA, Inc
ARTIS pheno and ARTIS Icono biplane, floor and ceiling. Model Numbers 10849000, 11327600, 11328100, 11327700.
Open, Classified		 OWBK241572
Feb 3, 2026Siemens Medical Solutions USA, Inc
NAEOTOM Alpha.Pro Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS
Open, Classified		 JAKK251061
Feb 3, 2026Siemens Medical Solutions USA, Inc
NAEOTOM Alpha.Prime Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS
Open, Classified		 JAKK251061
Feb 3, 2026Siemens Medical Solutions USA, Inc
NAEOTOM Alpha Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS
Open, Classified		 JAKK251061
Feb 3, 2026Siemens Medical Solutions USA, Inc
SOMATOM X.ceed Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS
Open, Classified		 JAKK233650
Jan 27, 2026Siemens Medical Solutions USA, Inc
Interventional Fluoroscopic X-Ray System: LUMINOS Q.namix T; Siemens Material Number (SMN): 11574003; With Software Version VB10D-SP02
Open, Classified		 OWBK250660
Jan 27, 2026Siemens Medical Solutions USA, Inc
Interventional Fluoroscopic X-Ray System: LUMINOS Q.namix R; Siemens Material Number (SMN): 11574002; With Software Version VB10D-SP02
Open, Classified		 OWBK250660
Jan 8, 2026Siemens Medical Solutions USA, Inc
LUMINOS Lotus Max, Model 11574100 and Luminos dRF Max, Model 10762471
Open, Classified		 OWBK173639
Dec 3, 2025Siemens Medical Solutions USA, Inc
MAMMOMAT Fusion;
Open, Classified		 MUEK151645
Dec 3, 2025Siemens Medical Solutions USA, Inc
MAMMOMAT Inspiration;
Open, Classified		 MUEK123520
Dec 3, 2025Siemens Medical Solutions USA, Inc
MAMMOMAT Revelation;
Open, Classified		 MUEK193166
Nov 12, 2025Siemens Medical Solutions USA, Inc
MAGNETOM Cima.X Upgrade. Model Number: 11689304.
Open, Classified		 LNHK231587
Sep 30, 2025Siemens Medical Solutions USA, Inc
MAGNETOM Vida Fit. Model Number: 11410481.
Open, Classified		 LNHK192924
K220939
Sep 30, 2025Siemens Medical Solutions USA, Inc
MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.
Open, Classified		 LNHK170396
K231560
Sep 30, 2025Siemens Medical Solutions USA, Inc
MAGNETOM Verio Dot Upgrade. Model Number: 10684334.
Open, Classified		 LNHK121434
K181613
Sep 30, 2025Siemens Medical Solutions USA, Inc
MAGNETOM Verio Dot. Model Number: 10684333.
Open, Classified		 LNHK121434
K181613
Sep 30, 2025Siemens Medical Solutions USA, Inc
MAGNETOM Verio. Model Number: 10276755.
Open, Classified		 LNHK072237
Sep 30, 2025Siemens Medical Solutions USA, Inc
MAGNETOM Spectra as the following: 1. MAGNETOM Spectra. Model Number: 10837643. 2. MAGNETOM Spectra (CN). Model Number: 10655588.
Open, Classified		 LNHK121160
Sep 30, 2025Siemens Medical Solutions USA, Inc
MAGNETOM Skyra Fit BioMatrix. Model Number: 11516217.
Open, Classified		 LNHK220589
K232494 +1
Sep 30, 2025Siemens Medical Solutions USA, Inc
MAGNETOM Skyra fit. Model Number: 10849580.
Open, Classified		 LNHK130885
K151579 +4
Sep 30, 2025Siemens Medical Solutions USA, Inc
MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.
Open, Classified		 LNHK101347
K231560
Sep 30, 2025Siemens Medical Solutions USA, Inc
MAGNETOM Prisma. Model Number: 10849582.
Open, Classified		 LNHK132119
K151579 +4
Sep 30, 2025Siemens Medical Solutions USA, Inc
MAGNETOM Lumina (DE). Model Number: 11344916.
Open, Classified		 LNHK183244
K192924 +2
Sep 30, 2025Siemens Medical Solutions USA, Inc
MAGNETOM Connectom.X. Model Number: 11371480.
Open, Classified		 LNHNone listed
Sep 30, 2025Siemens Medical Solutions USA, Inc
MAGNETOM Cima.X (DE). Model Number: 11647158.
Open, Classified		 LNHNone listed
Sep 30, 2025Siemens Medical Solutions USA, Inc
BIOGRAPH One (DE). Model Number: 11689172.
Open, Classified		 LNHK101347
Sep 30, 2025Siemens Medical Solutions USA, Inc
Biograph mMR. Model Number: 10433372.
Open, Classified		 OUOK200213
Sep 5, 2025Siemens Medical Solutions USA, Inc
Artis Pheno. Image-Intensified Flouroscopic X-Ray System.
Open, Classified		 OWBK241572
Jun 27, 2025Siemens Medical Solutions USA, Inc
interventional fluoroscopic x-ray system
Open, Classified		 OWBK241572
Jun 27, 2025Siemens Medical Solutions USA, Inc
interventional fluoroscopic x-ray system
Open, Classified		 OWBK241572
Jun 27, 2025Siemens Medical Solutions USA, Inc
interventional fluoroscopic x-ray system
Open, Classified		 OWBK241572
Jun 27, 2025Siemens Medical Solutions USA, Inc
ARTIS is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Proced
Open, Classified		 OWBK230949
Jun 17, 2025Siemens Medical Solutions USA, Inc
UROSKOP Omnia Max. Model Number: 10762473
Open, Classified		 JAAK101491
K173639
Jun 17, 2025Siemens Medical Solutions USA, Inc
UROSKOP Omnia. Model Number: 10094910
Open, Classified		 JAAK101491
K173639
Jan 29, 2025SIEMENS MEDICAL SOLUTIONS USA, INC
ARTIS One Angiographic X-Ray System
Open, Classified		 OWBK133580
Sep 24, 2024Siemens Medical Solutions USA, Inc.
ACUSON Maple 1.0 Diagnostic Ultrasound System, REF: 11711750, with software. ACUSON Maple Select 1.0 Diagnostic Ultrasound System, REF: 11711779, with software
Open, Classified		 IYNK232617
Sep 24, 2024Siemens Medical Solutions USA, Inc.
ACUSON Redwood 1.0 and 2.0 Diagnostic Ultrasound Systems, REF: 11503314, with software
Open, Classified		 IYNK210743
Sep 24, 2024Siemens Medical Solutions USA, Inc.
ACUSON Juniper 1.0, 1.5, 2.0, 2.5 Diagnostic Ultrasound Systems, REF: 11335791, with software. ACUSON Juniper Select 2.0, 2.5 Diagnostic Ultrasound Systems, REF: 11653093, with software.
Open, Classified		 IYNK201130
Aug 7, 2024Siemens Medical Solutions USA, Inc
Multitom Rax -Intended to visualize anatomical structures by converting an x-ray pattern into a visible image Model Number: 10860700
Open, Classified		 OWBK221281
Aug 7, 2024Siemens Medical Solutions USA, Inc
LUMINOS Lotus Max -Intended to visualize anatomical structures by converting an x-ray pattern into a visible image Model Number: 11574100
Open, Classified		 OWBK173639
Aug 7, 2024Siemens Medical Solutions USA, Inc
Luminos dRF Max- Intended to visualize anatomical structures by converting an x-ray pattern into a visible image. Model Number: 10762471
Open, Classified		 OWBK173639
Aug 7, 2024Siemens Medical Solutions USA, Inc
Luminos Agile Max -Intended to visualize anatomical structures by converting an x-ray pattern into a visible image. Model Number: 10762472
Open, Classified		 OWBK173639
Jul 25, 2024Siemens Medical Solutions USA, Inc
Sensis Vibe systems with software version VD15B-Intended to be used as a diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies, for cardiac as wel
Open, Classified		 DQKK223812

Newest 50 of 1,245.

Get alerts for these product codes