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) | K192835 | ACUSON NX3 Diagnostic Ultrasound System / ACUSON NX3 Elite Diagnostic Ultrasound System | IYN | 2019-10-22 | View |
| 510(k) | K192402 | syngo.CT Extended Functionality | JAK | 2019-09-20 | View |
| 510(k) | K192065 | Syngo.Via RT Image Suite | MUJ | 2019-09-18 | View |
| 510(k) | K190768 | ARTIS icono | OWB | 2019-09-12 | View |
| 510(k) | K183268 | AI-Rad Companion (Cardiovascular) | JAK | 2019-09-10 | View |
| 510(k) | K191922 | ACUSON P200 Diagnostic Ultrasound System | IYN | 2019-08-15 | View |
| 510(k) | K183271 | AI-Rad Companion (Pulmonary) | JAK | 2019-07-26 | View |
| 510(k) | K191050 | MAGNETOM Aera and MAGNETOM Skyra with Software syngo MR E11E with Ischemic Heart Disease (IHD) Workflow | LNH | 2019-07-12 | View |
| 510(k) | K182904 | syngo.MR Applications | LLZ | 2019-07-05 | View |
| 510(k) | K191468 | syngo.CT Dual Energy | JAK | 2019-07-03 | View |
| 510(k) | K190578 | SOMATOM Force, SOMATOM Definition Flash, SOMATOM Drive, SOMATOM Definition Edge, SOMATOM Definition AS Open, SOMATOM Edge Plus, SOMATOM Definition AS/AS+, SOMATOM Confidence | JAK | 2019-06-27 | View |
| 510(k) | K191418 | Multix Fusion Max | KPR | 2019-06-19 | View |
| 510(k) | K190900 | Biograph Vision | KPS | 2019-05-06 | View |
| 510(k) | K183548 | SOMATOM Perspective, SOMATOM Scope/Scope Power, SOMATOM Emotion 16 | JAK | 2019-04-15 | View |
| 510(k) | K190138 | MAGNETOM Aera | LNH | 2019-02-15 | View |
| 510(k) | K183222 | MAGNETOM Terra | LNH | 2019-02-15 | View |
| 510(k) | K183221 | MAGNETOM Amira, MAGNETOM Sempra | LNH | 2019-02-14 | View |
| 510(k) | K183272 | AI Rad Companion (Engine) | LLZ | 2019-02-01 | View |
| 510(k) | K183244 | MAGNETOM Lumina | LNH | 2019-01-24 | View |
| 510(k) | K183254 | Magnetom Vida | LNH | 2019-01-18 | View |
No matching devices.
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