FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
Caption Interpretation Automated Ejection Fraction Software
K Number: DEN220063
·
Decision Feb 24, 2023
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
0
Applicant Total
2
Review Days
149
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Basic Information
- Device Name
- Caption Interpretation Automated Ejection Fraction Software
- K Number
- DEN220063
- Device Class
- FDA class 2
- Clearance Type
- Direct
- Regulation Number
- 892.2055
- Medical Specialty
- Radiology
- Decision
- Unknown
- Applicant
- Caption Health, Inc.
- Date Received
- September 28, 2022
- Decision Date
- February 24, 2023
- Product Code
- QVD
- 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 |
|---|---|---|---|
| QVD | Radiological Machine Learning Based Quantitative Imaging Software With Change Control Plan | FDA class 2 | Radiology |
Other Clearances by Caption Health, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K243065 | Cardiac Guidance | Jan 15, 2025 | Substantially Equivalent |