FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Philips EPIQ Diagnostic Ultrasound System, Philips Affiniti Diagnostic Ultrasound System
K Number: K212704
·
Decision Sep 24, 2021
Classifications
1
FEI Numbers
220
Registration Numbers
220
Same Product Code
1171
Applicant Total
107
Review Days
29
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Basic Information
- Device Name
- Philips EPIQ Diagnostic Ultrasound System, Philips Affiniti Diagnostic Ultrasound System
- K Number
- K212704
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1550
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Philips Medical Systems
- Date Received
- August 26, 2021
- Decision Date
- September 24, 2021
- 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
·Radiology
Other Clearances by Philips Medical Systems
| K Number | Device Name | ||
|---|---|---|---|
| K211597 | EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System | Sep 8, 2021 | Substantially Equivalent |
| K210560 | Page Writer TC20 Cardiograph, Page Writer TC30 Cardiograph, Page Writer TC50 Cardiograph, Page Writer TC70 Cardiograph | Jun 30, 2021 | Substantially Equivalent |
| K191738 | PageWriter TC20 Cardiograph, PageWriter TC30 Cardiograph, PageWriter TC50 Cardiograph, PageWriter TC70 Cardiograph | Sep 29, 2020 | Substantially Equivalent |
| K192875 | Philips Biosensor BX100 | Apr 16, 2020 | Substantially Equivalent |
| K183387 | M3290B Patient Information Center iX | Aug 6, 2019 | Substantially Equivalent |
| K180017 | MX40 Release C.01 | Jul 24, 2018 | Substantially Equivalent |
| K172226 | MX40 Release B.07 | Nov 9, 2017 | Substantially Equivalent |
| K163584 | M3290B Philips IntelliVue Information Center iX | Jul 7, 2017 | Substantially Equivalent |
| K163649 | SureSigns VS3; SureSigns VS4 | Mar 31, 2017 | Substantially Equivalent |
| K161164 | CareEvent inclusive of the CareEvent Mobile Application accessory | Jun 24, 2016 | Substantially Equivalent |