Company profile

Siemens Medical Solutions USA, Inc.

Siemens Medical Solutions USA, Inc. has 67 AI-enabled medical devices on the FDA list. The first decision was on January 24, 2014 and the most recent on June 25, 2026 (syngo.CT Coronary Cockpit). Its most common review panel is Radiology (67 devices).

67AI devices

2014First decision

2026Latest decision

1Specialties

Per year

2014201720192020202120222023202420252026

Siemens Medical Solutions USA, Inc. AI devices per year: 2014 1, 2017 1, 2019 5, 2020 9, 2021 5, 2022 15, 2023 10, 2024 12, 2025 4, 2026 5

By specialty

Radiology67

Timeline

June 25, 2026 · 510(k) K253786syngo.CT Coronary Cockpit · Radiology · QIH
June 16, 2026 · 510(k) K260844ACUSON Sequoia Diagnostic Ultrasound System;ACUSON Sequoia Select Diagnostic Ultrasound System;ACUSON Origin Diagnostic Ultrasound System;ACUSON Origin ICE Diagnostic Ultrasound System · Radiology · IYN
April 29, 2026 · 510(k) K254184syngo Application Software · Radiology · QIH
March 20, 2026 · 510(k) K253574SOMATOM X.cite; SOMATOM X.ceed · Radiology · JAK
February 10, 2026 · 510(k) K254016MI View&GO · Radiology · QIH
August 20, 2025 · 510(k) K251481ACUSON Sequoia Diagnostic Ultrasound System; ACUSON Sequoia Select Diagnostic Ultrasound System; ACUSON Origin Diagnostic Ultrasound System; ACUSON Origin ICE Diagnostic Ultrasound System · Radiology · IYN
July 3, 2025 · 510(k) K251528syngo.via MI Workflows; Scenium; syngo MBF · Radiology · QIH
April 10, 2025 · 510(k) K243145syngo.CT LVO Detection · Radiology · QAS
February 12, 2025 · 510(k) K243523NAEOTOM Alpha.Peak/ NAEOTOM Alpha; NAEOTOM Alpha.Pro; NAEOTOM Alpha.Prime · Radiology · JAK
November 19, 2024 · 510(k) K242523ACUSON Sequoia Diagnostic Ultrasound System; ACUSON Sequoia Select Diagnostic Ultrasound System; ACUSON Origin Diagnostic Ultrasound System; ACUSON Origin ICE Diagnostic Ultrasound System · Radiology · IYN
September 23, 2024 · PMA P140011/S008MAMMOMAT B.brilliant with Tomosynthesis Option · Radiology · OTE
August 30, 2024 · 510(k) K242300MI View&GO · Radiology · QIH
August 30, 2024 · 510(k) K242275syngo.via MI Workflows; Scenium; syngo MBF · Radiology · QIH
July 22, 2024 · 510(k) K240704ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound System, ACUSON Origin Diagnostic Ultrasound System, ACUSON Origin ICE Diagnostic Ultrasound System · Radiology · IYN
April 26, 2024 · 510(k) K232799syngo.via RT Image Suite · Radiology · MUJ
March 28, 2024 · 510(k) K233657NAEOTOM Alpha · Radiology · JAK
March 26, 2024 · 510(k) K233650SOMATOM go.Up; SOMATOM go.Now; SOMATOM go.All; SOMATOM go.Top; SOMATOM go.Sim; SOMATOM go.Open Pro; SOMATOM X.cite; SOMATOM X.ceed · Radiology · JAK
March 22, 2024 · 510(k) K232322MAGNETOM Terra; MAGNETOM Terra.X · Radiology · LNH
March 22, 2024 · 510(k) K232431syngo.CT Brain Hemorrhage · Radiology · QAS
February 29, 2024 · 510(k) K232765MAGNETOM Cima.X Fit · Radiology · LNH
January 12, 2024 · 510(k) K233677Biograph VK10 · Radiology · KPS
December 22, 2023 · 510(k) K232535MAGNETOM Sola; MAGNETOM Altea · Radiology · LNH
December 18, 2023 · 510(k) K231587MAGNETOM Cima.X · Radiology · LNH
November 28, 2023 · 510(k) K232000syngo.via MI Workflows; Scenium; syngo MBF · Radiology · QIH
November 14, 2023 · 510(k) K232494MAGNETOM Avanto fit; MAGNETOM Skyra fit · Radiology · LNH
November 9, 2023 · 510(k) K231617MAGNETOM Free.Max; MAGNETOM Free.Star · Radiology · LNH
October 30, 2023 · 510(k) K232145ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound System, ACUSON Origin Diagnostic Ultrasound System · Radiology · IYN
October 23, 2023 · 510(k) K231560MAGNETOM Vida; MAGNETOM Lumina; MAGNETOM Aera; MAGNETOM Skyra; MAGNETOM Prisma; MAGNETOM Prisma fit · Radiology · LNH
September 6, 2023 · 510(k) K232482MAGNETOM Viato.Mobile · Radiology · LNH
July 13, 2023 · 510(k) K231833Biograph Vision.X and Biograph Vision.X Edge · Radiology · KPS
March 28, 2023 · 510(k) K223343MAGNETOM Amira; MAGNETOM Sempra · Radiology · LNH
November 14, 2022 · 510(k) K222428Syngo Dynamics (Version VA40F) · Radiology · QIH
October 20, 2022 · 510(k) K222361AI-Rad Companion (Musculoskeletal) · Radiology · JAK
October 14, 2022 · 510(k) K221305AI-Rad Companion Organs RT · Radiology · QKB
September 13, 2022 · 510(k) K221733MAGNETOM Sola, MAGNETOM Altea, MAGNETOM Sola Fit · Radiology · LNH
September 7, 2022 · 510(k) K220783syngo.via RT Image Suite · Radiology · MUJ
August 19, 2022 · 510(k) K222172MI View&GO · Radiology · QIH
July 13, 2022 · 510(k) K221727syngo.CT Extended Functionality · Radiology · JAK
June 24, 2022 · 510(k) K220575MAGNETOM Free.Max, MAGNETOM Free.Star · Radiology · LNH
May 17, 2022 · 510(k) K221219syngo.CT CaScoring · Radiology · JAK
May 13, 2022 · 510(k) K220589MAGNETOM Skyra Fit · Radiology · LNH
April 29, 2022 · 510(k) K220939MAGNETOM Lumina and MAGNETOM Vida Fit with syngo MR XA50A · Radiology · LNH
April 1, 2022 · 510(k) K220151MAGNETOM Avanto Fit · Radiology · LNH
February 25, 2022 · 510(k) K213693MAGNETOM Vida with syngo MR XA50A · Radiology · LNH
January 28, 2022 · 510(k) K203260syngo.CT Brain Hemorrhage · Radiology · QAS
January 20, 2022 · 510(k) K214019syngo.CT Extended Functionality · Radiology · JAK
December 6, 2021 · 510(k) K213096Al-Rad Companion (Pulmonary) · Radiology · JAK
July 30, 2021 · 510(k) K211379syngo.via RT Image Suite · Radiology · MUJ
July 1, 2021 · 510(k) K210611MAGNETOM Free.Max · Radiology · LNH
June 10, 2021 · 510(k) K211459syngo.via MI WorkFlows, Scenium, syngo MBF · Radiology · QIH
March 31, 2021 · 510(k) K203443MAGNETOM Vida, MAGNETOM Sola, MAGNETOM Lumina, MAGNETOM Altea · Radiology · LNH
November 18, 2020 · 510(k) K201195syngo.via MI Workflows, syngo MBF · Radiology · QIH
November 6, 2020 · 510(k) K193562AI-Rad Companion Organs RT · Radiology · QKB
August 13, 2020 · 510(k) K201444Syngo.via RT Image Suite · Radiology · MUJ
July 30, 2020 · 510(k) K193283AI-Rad Companion Prostate MR · Radiology · QIH
July 10, 2020 · 510(k) K193294AI-Rad Companion Engine · Radiology · LLZ
June 17, 2020 · 510(k) K193290AI-Rad Companion Brain MR · Radiology · LLZ
May 14, 2020 · 510(k) K201034Syngo.CT CaScoring · Radiology · JAK
March 16, 2020 · 510(k) K193267Al-Rad Companion (Musculoskeletal) · Radiology · JAK
February 14, 2020 · 510(k) K193248Biograph Vision, Biograph mCT Family of PET/CTs · Radiology · KPS
December 17, 2019 · 510(k) K192763syngo.CT CaScoring · Radiology · JAK
September 18, 2019 · 510(k) K192065Syngo.Via RT Image Suite · Radiology · MUJ
September 10, 2019 · 510(k) K183268AI-Rad Companion (Cardiovascular) · Radiology · JAK
July 26, 2019 · 510(k) K183271AI-Rad Companion (Pulmonary) · Radiology · JAK
February 1, 2019 · 510(k) K183272AI Rad Companion (Engine) · Radiology · LLZ
June 9, 2017 · 510(k) K170747syngo Application Software · Radiology · LLZ
January 24, 2014 · 510(k) K133259YSIO MAX · Radiology · KPR