FDA 510(k)
FDA class 2
Substantially Equivalent
🇧🇪 Belgium
FEops HEARTguideTM, FEops HEARTguideTM ALPACA
K Number: K223855
·
Decision Jun 6, 2023
Classifications
1
FEI Numbers
217
Registration Numbers
217
Same Product Code
303
Applicant Total
4
Review Days
165
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Basic Information
- Device Name
- FEops HEARTguideTM, FEops HEARTguideTM ALPACA
- K Number
- K223855
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Feops NV
- Date Received
- December 23, 2022
- Decision Date
- June 6, 2023
- 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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