15 devices · 2 companies · 2021 to 2026
Siemens Healthcare GmbH: AI-enabled devices on FDA's list
15 devices from Siemens Healthcare GmbH, 2021 to 2026, from 2 companies across 7 product codes. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (15 of 15 here), the regulation, and MAUDE report counts by product code.
Retrieved from FDA public records.
Product codes from Siemens Healthcare GmbH
- QIH · Automated Radiological Image Processing Software5
- QKB · Radiological Image Processing Software For Radiation Therapy2
- LNH · System, Nuclear Magnetic Resonance Imaging2
- JAK · System, X-Ray, Tomography, Computed2
- OEB · Lung Computed Tomography System, Computer-Aided Detection2
- QDQ · Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer1
- LLZ · System, Image Processing, Radiological1
Every device, newest decision first
| Decision | Device | Panel | Product code | FDA |
|---|---|---|---|---|
| AI-Rad Companion Organs RTK252548 · 510(k) | Radiology | QKB | database entry | |
| syngo DynamicsK253689 · 510(k) | Radiology | QIH | database entry | |
| AI-Rad Companion Brain MRK253057 · 510(k) | Radiology | QIH | database entry | |
| MAGNETOM SolaK252838 · 510(k) | Radiology | LNH | database entry | |
| MAGNETOM Avanto FitK250443 · 510(k) | Radiology | LNH | database entry | |
| syngo DynamicsK242551 · 510(k) | Radiology | QIH | database entry | |
| AI-Rad Companion Organs RTK242745 · 510(k) | Radiology | QKB | database entry | |
| Prostate MR AIK241770 · 510(k) | Radiology | QDQ | database entry | |
| Syngo Carbon Enterprise AccessK240294 · 510(k) | Radiology | LLZ | database entry | |
| AI-Rad CompanionK233753 · 510(k) | Radiology | JAK | database entry | |
| Syngo Carbon ClinicalsK232856 · 510(k) | Radiology | QIH | database entry | |
| syngo.CT Lung CADK231157 · 510(k) | Radiology | OEB | database entry | |
| AI-Rad CompanionK213713 · 510(k) | Radiology | JAK | database entry | |
| AI-Rad Companion Brain MRK213706 · 510(k) | Radiology | QIH | database entry | |
| syngo.CT Lung CADK203258 · 510(k) | Radiology | OEB | database entry |
Every company in the record, the whole record of FDA AI-enabled medical devices, or what Apodicta does on a medical record.