Siemens Medical Solutions USA, Inc.
FDA 510(k) & PMA Approved Devices — 252 products
Total Devices252
Categories18
Latest FDA decision2026-07-01
| Type | Number | Device Name | Code | Date | Actions |
|---|---|---|---|---|---|
| 510(k) | K251528 | syngo.via MI Workflows; Scenium; syngo MBF | QIH | 2025-07-03 | View |
| 510(k) | K250822 | SOMATOM go.Now; SOMATOM go.Up; SOMATOM go.All; SOMATOM go.Top; SOMATOM go.Sim; SOMATOM go.Open Pro; SOMATOM Pro.Pulse | JAK | 2025-07-03 | View |
| 510(k) | K243145 | syngo.CT LVO Detection | QAS | 2025-04-10 | View |
| 510(k) | K243523 | NAEOTOM Alpha.Peak/ NAEOTOM Alpha; NAEOTOM Alpha.Pro; NAEOTOM Alpha.Prime | JAK | 2025-02-12 | View |
| 510(k) | K241757 | syngo.CT Dual Energy | JAK | 2025-01-03 | View |
| 510(k) | K242523 | ACUSON Sequoia Diagnostic Ultrasound System; ACUSON Sequoia Select Diagnostic Ultrasound System; ACUSON Origin Diagnostic Ultrasound System; ACUSON Origin ICE Diagnostic Ultrasound System | IYN | 2024-11-19 | View |
| 510(k) | K243299 | ACUSON Redwood Diagnostic Ultrasound System | IYN | 2024-11-15 | View |
| 510(k) | K243186 | Symbia Pro.specta Q3 (11364751); Symbia Pro.specta X3 (11364752); Symbia Pro.specta X7 (11364753); Symbia Pro.specta VA30A Family | KPS | 2024-10-30 | View |
| 510(k) | K241572 | ARTIS icono (VE40A) (floor); ARTIS icono (VE40A) (biplane); ARTIS icono (VE40A) (ceiling); ARTIS pheno (VE40A) | OWB | 2024-10-22 | View |
| 510(k) | K241569 | syngo Application Software | LLZ | 2024-10-11 | View |
| 510(k) | K241295 | SOMATOM On.site | JAK | 2024-09-03 | View |
| 510(k) | K242275 | syngo.via MI Workflows; Scenium; syngo MBF | QIH | 2024-08-30 | View |
| 510(k) | K242300 | MI View&GO | QIH | 2024-08-30 | View |
| 510(k) | K240704 | ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound System, ACUSON Origin Diagnostic Ultrasound System, ACUSON Origin ICE Diagnostic Ultrasound System | IYN | 2024-07-22 | View |
| 510(k) | K233613 | ACUSON SC2000 Diagnostic Ultrasound System | IYO | 2024-06-12 | View |
| 510(k) | K233610 | ACUSON P500 Ultrasound System; ACUSON P500 ICE Ultrasound System | IYN | 2024-06-12 | View |
| 510(k) | K232799 | syngo.via RT Image Suite | MUJ | 2024-04-26 | View |
| 510(k) | K240608 | MAGNETOM Viato.Mobile | LNH | 2024-03-29 | View |
| 510(k) | K233657 | NAEOTOM Alpha | JAK | 2024-03-28 | View |
| 510(k) | K233539 | MAMMOMAT B.brilliant | MUE | 2024-03-27 | View |
No matching devices.
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