FDA 510(k)
FDA class 2
Substantially Equivalent
🇫🇷 France
Fetal EchoScan (v1.1)
K Number: K251071
·
Decision May 2, 2025
Classifications
1
FEI Numbers
17
Registration Numbers
17
Same Product Code
21
Applicant Total
5
Review Days
25
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Basic Information
- Device Name
- Fetal EchoScan (v1.1)
- K Number
- K251071
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 892.2060
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Brightheart
- Date Received
- April 7, 2025
- Decision Date
- May 2, 2025
- Product Code
- POK
- 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 |
|---|---|---|---|
| POK | Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer | FDA class 2 | Radiology |
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