FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Ultrasound Workspace (UWS 6.0)
K Number: K241659
·
Decision Feb 10, 2025
Classifications
1
FEI Numbers
217
Registration Numbers
217
Same Product Code
303
Applicant Total
23
Review Days
245
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Basic Information
- Device Name
- Ultrasound Workspace (UWS 6.0)
- K Number
- K241659
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Philips Ultrasound, LLC
- Date Received
- June 10, 2024
- Decision Date
- February 10, 2025
- Product Code
- QIH
- 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 |
|---|---|---|---|
| QIH | Automated Radiological Image Processing Software | FDA class 2 | Radiology |
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Other Clearances by Philips Ultrasound, LLC
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|---|---|---|---|
| K260123 | EPIQ Series Diagnostic Ultrasound System | May 27, 2026 | Substantially Equivalent |
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| 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 |