FDA device listing
Achieva R4 1.5T (Ingenia),Achieva R4 3.0T (ingenia),dS MICROSCOPY 23MM COIL, INGENIA 1.5T,dS MICROSCOPY 23MM COIL…
FDA device listing 1659591418 · Philips Medical Systems International BV
Key facts
| Proprietary names | Achieva R4 1.5T (Ingenia),Achieva R4 3.0T (ingenia),dS MICROSCOPY 23MM COIL, INGENIA 1.5T,dS MICROSCOPY 23MM COIL, INGENIA 3.0T,dS MICROSCOPY 47MM COIL, INGENIA 1.5T,dS MICROSCOPY 47MM COIL, INGENIA 3.0T,Ingenia 1.5T,Ingenia 3.0T,Ingenia CX 1.5T,Ingenia CX 3.0T,MICROSCOPY COIL SET, INGENIA 1.5T,MICROSCOPY COIL SET, INGENIA 3.0T,wBTS Sensor Set, ECG 1.0 meter - 98980319364X,wBTS wPPU Sensor… |
|---|---|
| Owner/operator | Philips Medical Systems International BV |
| Owner/operator number | 1217116 |
| Premarket submissions | K110151 |
| Product codes | LNH |
| Device names | LNH - System, Nuclear Magnetic Resonance Imaging |
| Device class | Class II |
| Classification regulations (21 CFR) | 892.1000 |
| Review panels | Radiology |
| Registered establishments | Philips Electronics Ltd, Philips Global Business Services LLP, Philips India Limited - Magnetic Resonance Business Unit, PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Establishment registrations | 3000126629, 3016851825, 3033527281, 3042177665 |
| FEI numbers | 3000126629, 3016851825, 3033527281, 3042177665 |
| Establishment operations | Complaint File Establishment, Specification Developer, Foreign Exporter, 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