FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems
K Number: K260680
·
Decision May 27, 2026
Classifications
1
FEI Numbers
220
Registration Numbers
220
Same Product Code
1171
Applicant Total
23
Review Days
86
Basic Information
- Device Name
- EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems
- K Number
- K260680
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 892.1550
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Philips Ultrasound, LLC
- Date Received
- March 2, 2026
- Decision Date
- May 27, 2026
- Product Code
- IYN
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- Third Party
- N
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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Other Clearances by Philips Ultrasound, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K260123 | EPIQ Series Diagnostic Ultrasound System | May 27, 2026 | Substantially Equivalent |
| K252558 | Lumify Diagnostic Ultrasound System | May 5, 2026 | Substantially Equivalent |
| K253595 | EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System | Mar 27, 2026 | Substantially Equivalent |
| K252557 | Lumify Diagnostic Ultrasound System | Dec 22, 2025 | Substantially Equivalent |
| K251651 | EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System | Oct 9, 2025 | Substantially Equivalent |
| K251455 | EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System | Jul 24, 2025 | Substantially Equivalent |
| K250886 | EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems | Jun 18, 2025 | Substantially Equivalent |
| K243793 | EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System | May 21, 2025 | Substantially Equivalent |
| K251110 | EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems | May 9, 2025 | Substantially Equivalent |
| K250030 | Flash Ultrasound System 5100 Point of Care | Apr 28, 2025 | Substantially Equivalent |