FDA device listing
Achieva 1.5T family,ANTERIOR - SYN HEAD/NECK COIL 4598-000-5192x,CIRC.COIL C1 1.5T 4598-000-5184x,CIRC.COIL C3 1.5T…
FDA device listing 1604899452 · Philips Medical Systems International BV
Key facts
| Proprietary names | Achieva 1.5T family,ANTERIOR - SYN HEAD/NECK COIL 4598-000-5192x,CIRC.COIL C1 1.5T 4598-000-5184x,CIRC.COIL C3 1.5T 4598-000-5196x,Intera 1.5T family,MICRO 23MM COIL 4598-000-5197x,MICRO 47MM COIL 4598-000-5198x,MRI COILS,POSTERIOR - SYN HEAD/NECK COIL 4598-000-5193x,QUAD HEAD COIL 1.5T 4522-133-1727x,SENSE CARDIAC COIL 4522-133-1725x,SENSE CARDIAC COIL 4522-133-1726x,SENSE FLEX L COIL 1.5T… |
|---|---|
| Owner/operator | Philips Medical Systems International BV |
| Owner/operator number | 1217116 |
| Premarket submissions | K052013 |
| 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 India Limited - Magnetic Resonance Business Unit, PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Establishment registrations | 3000126629, 3003768277, 3033527281, 3042177665 |
| FEI numbers | 3000126629, 3002807880, 3033527281, 3042177665 |
| Establishment operations | Complaint File Establishment, Specification Developer, Contract Manufacturer, Foreign Exporter |
| 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