FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
QLAB Advanced Quantification Software
K Number: K200974
·
Decision Jun 3, 2020
Classifications
1
FEI Numbers
217
Registration Numbers
217
Same Product Code
303
Applicant Total
20
Review Days
51
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Basic Information
- Device Name
- QLAB Advanced Quantification Software
- K Number
- K200974
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Philips Health Care
- Date Received
- April 13, 2020
- Decision Date
- June 3, 2020
- 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 Health Care
| K Number | Device Name | ||
|---|---|---|---|
| K201352 | 3D Auto LAA | Aug 17, 2020 | Substantially Equivalent |
| K200179 | Collaboration Live | Feb 18, 2020 | Substantially Equivalent |
| K191647 | QLAB Advanced Quantification Software | Dec 20, 2019 | Substantially Equivalent |
| K192226 | Lumify Diagnostic Ultrasound System | Sep 6, 2019 | Substantially Equivalent |
| K190913 | QLAB Advanced Quantification Software 13 | Jun 18, 2019 | Substantially Equivalent |
| K172607 | Philips 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 | Oct 4, 2017 | Substantially Equivalent |
| K171314 | QLAB Advanced Quantification Software | May 30, 2017 | Substantially Equivalent |
| K163020 | Xperius Ultrasound System | Nov 16, 2016 | Substantially Equivalent |
| K162549 | Lumify Ultrasound System | Oct 3, 2016 | Substantially Equivalent |
| K162329 | CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound System | Sep 14, 2016 | Substantially Equivalent |