Siemens Medical Solutions USA, Inc.
56 AI-enabled device listings under this company name on the FDA list. The name is copied as published. It is not a review of the company.
| Date | Submission | Device | Panel | Code |
|---|---|---|---|---|
| June 25, 2026 | K253786 | syngo.CT Coronary Cockpit | Radiology | QIH |
| June 16, 2026 | K260844 | ACUSON 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 | K254184 | syngo Application Software | Radiology | QIH |
| March 20, 2026 | K253574 | SOMATOM X.cite; SOMATOM X.ceed | Radiology | JAK |
| February 10, 2026 | K254016 | MI View&GO | Radiology | QIH |
| August 20, 2025 | K251481 | ACUSON 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 | K251528 | syngo.via MI Workflows; Scenium; syngo MBF | Radiology | QIH |
| April 10, 2025 | K243145 | syngo.CT LVO Detection | Radiology | QAS |
| February 12, 2025 | K243523 | NAEOTOM Alpha.Peak/ NAEOTOM Alpha; NAEOTOM Alpha.Pro; NAEOTOM Alpha.Prime | Radiology | JAK |
| November 19, 2024 | K242523 | ACUSON Sequoia Diagnostic Ultrasound System; ACUSON Sequoia Select Diagnostic Ultrasound System; ACUSON Origin Diagnostic Ultrasound System; ACUSON Origin ICE Diagnostic Ultrasound System | Radiology | IYN |
| August 30, 2024 | K242275 | syngo.via MI Workflows; Scenium; syngo MBF | Radiology | QIH |
| August 30, 2024 | K242300 | MI View&GO | Radiology | QIH |
| April 26, 2024 | K232799 | syngo.via RT Image Suite | Radiology | MUJ |
| March 28, 2024 | K233657 | NAEOTOM Alpha | Radiology | JAK |
| March 26, 2024 | K233650 | SOMATOM 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 | K232322 | MAGNETOM Terra; MAGNETOM Terra.X | Radiology | LNH |
| March 22, 2024 | K232431 | syngo.CT Brain Hemorrhage | Radiology | QAS |
| February 29, 2024 | K232765 | MAGNETOM Cima.X Fit | Radiology | LNH |
| January 12, 2024 | K233677 | Biograph VK10 | Radiology | KPS |
| December 22, 2023 | K232535 | MAGNETOM Sola; MAGNETOM Altea | Radiology | LNH |
| December 18, 2023 | K231587 | MAGNETOM Cima.X | Radiology | LNH |
| November 28, 2023 | K232000 | syngo.via MI Workflows; Scenium; syngo MBF | Radiology | QIH |
| November 14, 2023 | K232494 | MAGNETOM Avanto fit; MAGNETOM Skyra fit | Radiology | LNH |
| November 9, 2023 | K231617 | MAGNETOM Free.Max; MAGNETOM Free.Star | Radiology | LNH |
| October 30, 2023 | K232145 | ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound System, ACUSON Origin Diagnostic Ultrasound System | Radiology | IYN |
| October 23, 2023 | K231560 | MAGNETOM Vida; MAGNETOM Lumina; MAGNETOM Aera; MAGNETOM Skyra; MAGNETOM Prisma; MAGNETOM Prisma fit | Radiology | LNH |
| September 6, 2023 | K232482 | MAGNETOM Viato.Mobile | Radiology | LNH |
| July 13, 2023 | K231833 | Biograph Vision.X and Biograph Vision.X Edge | Radiology | KPS |
| November 14, 2022 | K222428 | Syngo Dynamics (Version VA40F) | Radiology | QIH |
| October 20, 2022 | K222361 | AI-Rad Companion (Musculoskeletal) | Radiology | JAK |
| September 13, 2022 | K221733 | MAGNETOM Sola, MAGNETOM Altea, MAGNETOM Sola Fit | Radiology | LNH |
| August 19, 2022 | K222172 | MI View&GO | Radiology | QIH |
| July 13, 2022 | K221727 | syngo.CT Extended Functionality | Radiology | JAK |
| June 24, 2022 | K220575 | MAGNETOM Free.Max, MAGNETOM Free.Star | Radiology | LNH |
| May 17, 2022 | K221219 | syngo.CT CaScoring | Radiology | JAK |
| May 13, 2022 | K220589 | MAGNETOM Skyra Fit | Radiology | LNH |
| April 1, 2022 | K220151 | MAGNETOM Avanto Fit | Radiology | LNH |
| February 25, 2022 | K213693 | MAGNETOM Vida with syngo MR XA50A | Radiology | LNH |
| January 28, 2022 | K203260 | syngo.CT Brain Hemorrhage | Radiology | QAS |
| January 20, 2022 | K214019 | syngo.CT Extended Functionality | Radiology | JAK |
| December 6, 2021 | K213096 | Al-Rad Companion (Pulmonary) | Radiology | JAK |
| July 1, 2021 | K210611 | MAGNETOM Free.Max | Radiology | LNH |
| June 10, 2021 | K211459 | syngo.via MI WorkFlows, Scenium, syngo MBF | Radiology | QIH |
| March 31, 2021 | K203443 | MAGNETOM Vida, MAGNETOM Sola, MAGNETOM Lumina, MAGNETOM Altea | Radiology | LNH |
| November 18, 2020 | K201195 | syngo.via MI Workflows, syngo MBF | Radiology | QIH |
| November 6, 2020 | K193562 | AI-Rad Companion Organs RT | Radiology | QKB |
| August 13, 2020 | K201444 | Syngo.via RT Image Suite | Radiology | MUJ |
| July 10, 2020 | K193294 | AI-Rad Companion Engine | Radiology | LLZ |
| June 17, 2020 | K193290 | AI-Rad Companion Brain MR | Radiology | LLZ |
| May 14, 2020 | K201034 | Syngo.CT CaScoring | Radiology | JAK |
| March 16, 2020 | K193267 | Al-Rad Companion (Musculoskeletal) | Radiology | JAK |
| December 17, 2019 | K192763 | syngo.CT CaScoring | Radiology | JAK |
| September 18, 2019 | K192065 | Syngo.Via RT Image Suite | Radiology | MUJ |
| September 10, 2019 | K183268 | AI-Rad Companion (Cardiovascular) | Radiology | JAK |
| July 26, 2019 | K183271 | AI-Rad Companion (Pulmonary) | Radiology | JAK |
| February 1, 2019 | K183272 | AI Rad Companion (Engine) | Radiology | LLZ |