| Proprietary Name: |
459801729901 - dS Breast 7ch 1.5T; 459801729911 - dS Breast 7ch 3.0T; Biopsy Breast Coil; Coil/ASM/Breast Coil for Echelon; dS Breast 16ch 1.5T; Fiducial Holder, Needle Hub Assembly,; GE Excite 1.5T 7CH BBC; GE Excite 1.5T 7Ch Biopsy Breast Array; GE Excite HDx 1.5T 7ch BBC; GE Excite HDx 1.5T HDx 7CH BBC; GE HDx 3.0T 7Ch Biopsy Breast; GE LBS 1.5T16CH; GE LBS 3.0T 16CH; GE LBS 3.0T 7CH; Grid Immobilization Plate BBC, Pillar Immobilization Plate BBC, Pillar Immobilization Plate,; Grid Immobilization Plate LBS, Pillar Immobilization Plate LBS, Needle Block Holder,; HITACHI 1.5T 7C BREAST; LBS 3.0T SMS 7 ch; MammoTrak Interventional Breast Coil 1.5T; Philip Interventional Coil 3.0T, PHC, Achieva TX; PHILIPS 1.5T INTERA ACHIEVA (CDAS) BBC; Philips 7ch SENSE Breast Coil 1.5T; Philips dS Breast 7ch 1.5T; Philips dS Breast 7ch 3.0T; Siemens 1.5T Symphony 7Ch BBC (Breast Biopsy Coil); Siemens AVANTO 1.5T BBC; Siemens Luminescence 1.5T Breast Coil 16 Ch; Siemens Luminescence 1.5T Breast Coil 7 Ch; Siemens Luminescence 3.0T Breast Coil 16 Ch; Siemens SYMPHONY 1.5T BBC; Toshiba 1.5T 7CH BBC |
| Classification Name: |
COIL, MAGNETIC RESONANCE, SPECIALTY |
| Product Code: |
MOS |
| Device Class: |
2 |
| Regulation Number: |
892.1000 |
| Medical Specialty: |
Radiology |
| Registered Establishment Name: |
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
|
| Registered Establishment Number: |
3003768277
|
| Premarket Submission Number: |
K032576 |
| Owner/Operator: |
Philips Medical Systems International BV |
| Owner/Operator Number: |
1217116
|
| Establishment Operations: |
Specification Developer
|
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