FDA device listing
Biograph mCT,Biograph mCT 20 Excel,Biograph mCT Flow,Biograph mCT Flow 20,Biograph mCT Flow 20-3R,Biograph mCT Flow…
FDA device listing 1020053393 · SIEMENS MEDICAL SOLUTIONS USA, INC.
Key facts
| Proprietary names | Biograph mCT,Biograph mCT 20 Excel,Biograph mCT Flow,Biograph mCT Flow 20,Biograph mCT Flow 20-3R,Biograph mCT Flow 20-4R,Biograph mCT Flow 40,Biograph mCT Flow 40-3R,Biograph mCT Flow 40-4R,Biograph mCT Flow 64,Biograph mCT Flow 64-3R,Biograph mCT Flow 64-4R,Biograph mCT Flow Edge,Biograph mCT Flow Edge-3R,Biograph mCT Flow Edge-4R,Biograph mCT S,Biograph mCT S (20)-3R,Biograph mCT S(20)-3R (aka… |
|---|---|
| Owner/operator | SIEMENS MEDICAL SOLUTIONS USA, INC. |
| Owner/operator number | 9002915 |
| Premarket submissions | K151486 |
| Product codes | JAK, KPS |
| Device names | JAK - System, X-Ray, Tomography, Computed, KPS - System, Tomography, Computed, Emission |
| Device class | Class II |
| Classification regulations (21 CFR) | 892.1200, 892.1750 |
| Review panels | Radiology |
| Registered establishments | SIEMENS MEDICAL SOLUTIONS USA, INC. |
| Establishment registrations | 1034973, 1423253 |
| FEI numbers | 1034973, 1000514697 |
| Establishment operations | Manufacturer, Remanufacturer, Specification Developer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 10–99 UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database