Company ยท DE
Siemens Healthineers AG
FDA 510(k) clearances and medical device recalls filed under this name, 2019 to 2026. Name variants (Inc, Corp, punctuation) are merged.
8510(k) clearances (5 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| LLZ | System, Image Processing, Radiological | 2 |
| QIH | Automated Radiological Image Processing Software | 2 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 1 |
| KPS | System, Tomography, Computed, Emission | 1 |
| LNH | System, Nuclear Magnetic Resonance Imaging | 1 |
| OUO | Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 29, 2026 | K263048 | Syngo Carbon Space (VA4) Siemens Healthineers AG, DE | LLZ |
| Jul 31, 2026 | K260852 | MAGNETOM Flow.Elite;MAGNETOM Flow.Neo;MAGNETOM Flow.Rise;MAGNETOM Flow.Pure Siemens Healthineers AG, DE | LNH |
| Jun 15, 2026 | K253690 | LungMaps Siemens Healthineers AG, DE | QIH |
| Jan 15, 2026 | K253023 | BIOGRAPH One Siemens Healthineers AG, DE | OUO |
| Nov 20, 2025 | K253495 | syngo.MR Applications (VB80) Siemens Healthineers AG, DE | LLZ |
| Oct 24, 2025 | K251059 | Syngo Carbon Clinicals (VA41) Siemens Healthineers AG, DE | QIH |
| Jul 26, 2024 | K241898 | Symbia SPECT and SPECT/CT Systems Siemens Healthineers | KPS |
| Mar 20, 2019 | K183575 | ACUSON S3000, S2000 Diagnostic Ultrasound System Siemens Healthineers | IYN |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||