EPIQ Diagnostic Ultrasound System, EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System, Affiniti 30 Diagnostic Ultrasound System, Affiniti 50 Diagnostic Ultrasound System, Affiniti 70 Diagnostic Ultrasound System
FDA 510(k) clearance K182857 · decided 2018-11-09
Clearance details
- K-number
- K182857
- Device name
- EPIQ Diagnostic Ultrasound System, EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System, Affiniti 30 Diagnostic Ultrasound System, Affiniti 50 Diagnostic Ultrasound System, Affiniti 70 Diagnostic Ultrasound System
- Applicant
- Philips Ultrasound, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2018-10-10
- Decision date
- 2018-11-09
- Days to decision
- 30 days
- Clearance type
- Traditional
- Product code
- IYN
- Device class
- 2
- Regulation number
- 892.1550
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Bothell, WA, US
- Third-party review
- Yes
- Expedited review
- No
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