FDA device listing
Collimator AIC Family,Collimator Angio Family,Collimator CARD Family,Collimator LFD Family,Collimator Mammo…
FDA device listing 1082830297 · Siemens Healthineers AG
Key facts
| Proprietary names | Collimator AIC Family,Collimator Angio Family,Collimator CARD Family,Collimator LFD Family,Collimator Mammo Family,Collimator MFD Family,Collimator ML02 Family,Collimator ML03,Collimator Mobile-C Family,Collimator N Family,Collimator N / N II Family,Collimator RFU Family,Collimator SFD Family |
|---|---|
| Owner/operator | Siemens Healthineers AG |
| Owner/operator number | 8010024 |
| Premarket submissions | K781984 |
| Product codes | KPW |
| Device names | KPW - Device, Beam Limiting, X-Ray, Diagnostic |
| Device class | Class II |
| Classification regulations (21 CFR) | 892.1610 |
| Review panels | Radiology |
| Registered establishments | Siemens Healthineers AG, SIEMENS SHANGHAI, MEDICAL EQUIPMENT LTD. |
| Establishment registrations | 3002466018, 3003202425 |
| FEI numbers | 3002466018, 3003202425 |
| Establishment operations | Complaint File Establishment, Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None 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