FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Automated Aortic Stenosis Software (AutoAS)
K Number: K254161
·
Decision Mar 27, 2026
Classifications
1
FEI Numbers
17
Registration Numbers
17
Same Product Code
21
Applicant Total
14
Review Days
95
Basic Information
- Device Name
- Automated Aortic Stenosis Software (AutoAS)
- K Number
- K254161
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2060
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC
- Date Received
- December 22, 2025
- Decision Date
- March 27, 2026
- 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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