| Proprietary Name: |
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 4522-133-1714x; SENSE FLEX L COIL 1.5T ODU 4522-133-1715x; SENSE FLEX M COIL 1.5T 4522-133-1716x; SENSE FLEX M COIL 1.5T ODU 4522-133-1717x; SENSE FLEX S COIL 1.5T 4522-133-1718x; SENSE FLEX S COIL 1.5T ODU 4522-133-1719x; SENSE SPINE COIL 1.5T 4522-133-1723x; SENSE SPINE COIL 1.5T ODU 4522-133-1724x; SHNC DRIVERBOX 1.5T 4598-000-5181x; SHNC DRIVERBOX 1.5T ODU 4598-000-5182x; SYN.BODY COIL 1.5T ODU 4598-005-5189x; SYN.BODY COIL 1.5T ODU WITH SLEEVE 4598-009-6978x; SYN.BODY COIL 1.5T WITH SLEEVE 4598-000-5187x; T/R Head Coil 1.5T (QHC 1H T/R ACS-NT-L) 4598-002-0529x |
| Classification Name: |
SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING |
| Product Code: |
LNH |
| Device Class: |
2 |
| Regulation Number: |
892.1000 |
| Medical Specialty: |
Radiology |
| Registered Establishment Name: |
Philips Electronics Ltd
|
| Registered Establishment Number: |
3000126629
|
| Premarket Submission Number: |
K052013 |
| Owner/Operator: |
Philips Medical Systems International BV |
| Owner/Operator Number: |
1217116
|
| Establishment Operations: |
Foreign Exporter
|
