FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EPIQ Series Diagnostic Ultrasound Systems
K Number: K202216
·
Decision Sep 2, 2020
Classifications
1
FEI Numbers
220
Registration Numbers
220
Same Product Code
1171
Applicant Total
46
Review Days
27
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Basic Information
- Device Name
- EPIQ Series Diagnostic Ultrasound Systems
- K Number
- K202216
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1550
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Philips Ultrasound, Inc.
- Date Received
- August 6, 2020
- Decision Date
- September 2, 2020
- Product Code
- IYN
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- Third Party
- Y
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | FDA class 2 | Radiology |
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FDA 510(k)
FDA Class 2
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Other Clearances by Philips Ultrasound, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K212777 | Collaboration Live | Sep 24, 2021 | Substantially Equivalent |
| K203406 | Lumify Diagnostic Ultrasound System | Feb 23, 2021 | Substantially Equivalent |
| K200603 | AAA Model | Sep 20, 2020 | Substantially Equivalent |
| K201665 | Collaboration Live | Sep 15, 2020 | Substantially Equivalent |
| K201053 | PercuNav Image Fusion and Interventional Navigation | May 14, 2020 | Substantially Equivalent |
| K201012 | EPIQ Diagnostic Ultrasound System Series, Affiniti Diagnostic Ultrasound System Series, CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound System, Lumify Diagnostic Ultrasound System | May 1, 2020 | Substantially Equivalent |
| K200304 | EPIQ Diagnostic Ultrasound System | Mar 6, 2020 | Substantially Equivalent |
| K182857 | 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 | Nov 9, 2018 | Substantially Equivalent |
| K182529 | Xperius Ultrasound System | Oct 23, 2018 | Substantially Equivalent |
| K181485 | EPIQ , EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 50 and Affiniti 70 Diagnostic Ultrasound System | Jul 27, 2018 | Substantially Equivalent |