Medical Device Manufacturer · US , Hoffman Estates , IL

Siemens Medical Solutions USA, Inc.

774 submissions · 774 cleared · Since 1980
774
Total
774
Cleared
0
Denied

Siemens Medical Solutions USA, Inc. — FDA 510(k) Submissions

Siemens Medical Solutions USA, Inc. has submitted 774 FDA 510(k) premarket notifications since 1980, of which 774 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include System, Nuclear Magnetic Resonance Imaging, System, X-ray, Tomography, Computed, System, Imaging, Pulsed Doppler, Ultrasonic, System, Image Processing, Radiological, System, Tomography, Computed, Emission . Use the specialty filter in the sidebar to narrow results.

774 devices
1–25 of 774
MI View&GO
K254016 · QIH Automated Radiological... · Radiology
Feb 2026 57d
ACUSON Maple Diagnostic Ultrasound System; ACUSON Maple Select Diagnostic Ultrasound System
K253487 · IYN System, Imaging, Pulsed... · Radiology
Nov 2025 27d
ACUSON Juniper Diagnostic Ultrasound System; ACUSON Juniper Select Diagnostic Ultrasound System
K253457 · IYN System, Imaging, Pulsed... · Radiology
Nov 2025 38d
Cios Select
K250241 · OWB Interventional... · Radiology
Nov 2025 281d
syngo.CT Dual Energy
K251805 · JAK System, X-ray,... · Radiology
Oct 2025 125d
ACUSON Sequoia Diagnostic Ultrasound System; ACUSON Sequoia Select Diagnostic Ultrasound System; ACUSON Origin Diagnostic Ultrasound System; ACUSON Origin ICE Diagnostic Ultrasound System
K251481 · IYN System, Imaging, Pulsed... · Radiology
Aug 2025 99d
Biograph Trinion
K251561 · KPS System, Tomography,... · Radiology
Jul 2025 71d
Cios Spin
K251523 · OWB Interventional... · Radiology
Jul 2025 74d
NAEOTOM Alpha.Peak/NAEOTOM Alpha; NAEOTOM Alpha.Pro; NAEOTOM Alpha.Prime
K251061 · JAK System, X-ray,... · Radiology
Jul 2025 115d
Cios Alpha; Cios Flow
K251520 · OWB Interventional... · Radiology
Jul 2025 54d
SOMATOM go.Now; SOMATOM go.Up; SOMATOM go.All; SOMATOM go.Top; SOMATOM go.Sim; SOMATOM go.Open Pro; SOMATOM Pro.Pulse
K250822 · JAK System, X-ray,... · Radiology
Jul 2025 107d
syngo.via MI Workflows; Scenium; syngo MBF
K251528 · QIH Automated Radiological... · Radiology
Jul 2025 45d
Biograph Vision PET/CT Systems; Biograph mCT PET/CT Systems
K251671 · KPS System, Tomography,... · Radiology
Jul 2025 34d
syngo.CT LVO Detection
K243145 · QAS Radiological... · Radiology
Apr 2025 192d
NAEOTOM Alpha.Peak/ NAEOTOM Alpha; NAEOTOM Alpha.Pro; NAEOTOM Alpha.Prime
K243523 · JAK System, X-ray,... · Radiology
Feb 2025 90d
syngo.CT Dual Energy
K241757 · JAK System, X-ray,... · Radiology
Jan 2025 199d
ACUSON Sequoia Diagnostic Ultrasound System; ACUSON Sequoia Select Diagnostic Ultrasound System; ACUSON Origin Diagnostic Ultrasound System; ACUSON Origin ICE Diagnostic Ultrasound System
K242523 · IYN System, Imaging, Pulsed... · Radiology
Nov 2024 88d
ACUSON Redwood Diagnostic Ultrasound System
K243299 · IYN System, Imaging, Pulsed... · Radiology
Nov 2024 28d
Symbia Pro.specta Q3 (11364751); Symbia Pro.specta X3 (11364752); Symbia Pro.specta X7 (11364753); Symbia Pro.specta VA30A Family
K243186 · KPS System, Tomography,... · Radiology
Oct 2024 30d
ARTIS icono (VE40A) (floor); ARTIS icono (VE40A) (biplane); ARTIS icono (VE40A) (ceiling); ARTIS pheno (VE40A)
K241572 · OWB Interventional... · Radiology
Oct 2024 144d
syngo Application Software
K241569 · LLZ System, Image Processing,... · Radiology
Oct 2024 133d
SOMATOM On.site
K241295 · JAK System, X-ray,... · Radiology
Sep 2024 118d
syngo.via MI Workflows; Scenium; syngo MBF
K242275 · QIH Automated Radiological... · Radiology
Aug 2024 29d
MI View&GO
K242300 · QIH Automated Radiological... · Radiology
Aug 2024 28d
ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound System, ACUSON Origin Diagnostic Ultrasound System, ACUSON Origin ICE Diagnostic Ultrasound System
K240704 · IYN System, Imaging, Pulsed... · Radiology
Jul 2024 130d

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