| Proprietary Name: |
3D9-3v; Affiniti 50 Diagnostic Ultrasound System; Affiniti 50C Diagnostic Ultrasound System; Affiniti 50G Diagnostic Ultrasound System; Affiniti 50W Diagnostic Ultrasound System; Affiniti 70 Diagnostic Ultrasound System; Affiniti 70C Diagnostic Ultrasound System; Affiniti 70G Diagnostic Ultrasound System; Affiniti 70W Diagnostic Ultrasound System; BP10-5ec; C10-3v; C10-4ec; C5-1; C6-2; C8-5; C9-2; C9-4v; D2cwc; D2tcd; D5cwc; eL18-4; EPIQ 5 Diagnostic Ultrasound System; EPIQ 5C Diagnostic Ultrasound System; EPIQ 5G Diagnostic Ultrasound System; EPIQ 5W Diagnostic Ultrasound System; EPIQ 7 Diagnostic Ultrasound System; EPIQ 7C Diagnostic Ultrasound System; EPIQ 7G Diagnostic Ultrasound System; EPIQ 7W Diagnostic Ultrasound System; EPIQ CVx Diagnostic Ultrasound System; EPIQ CVxi Diagnostic Ultrasound System; EPIQ Diagnostic Ultrasound System; EPIQ Elite Diagnostic Ultrasound System; EPIQ Elite W Diagnostic Ultrasound System; L12-3; L12-3 ERGO; L12-4; L12-5 50; L15-7io; L18-5; mC7-2; S12-4; S4-2; S5-1; S7-3t; S8-3; S8-3t; S9-2; V6-2; V9-2; VL13-5; X5-1; X5-1c; X6-1; X7-2; X7-2t; X8-2t; X8-2ti; XL14-3 |
| Classification Name: |
TRANSDUCER, ULTRASONIC, DIAGNOSTIC |
| Product Code: |
ITX |
| Device Class: |
2 |
| Regulation Number: |
892.1570 |
| Medical Specialty: |
Radiology |
| Registered Establishment Name: |
Philips Electronics Ltd
|
| Registered Establishment Number: |
3000126629
|
| Premarket Submission Number: |
K182857 |
| Owner/Operator: |
Philips Medical Systems International BV |
| Owner/Operator Number: |
1217116
|
| Establishment Operations: |
Foreign Exporter
|
