FDA 510(k)
FDA class 2
Substantially Equivalent
🇸🇬 Singapore
Us2.v1
K Number: K210791
·
Decision Jul 27, 2021
Classifications
1
FEI Numbers
217
Registration Numbers
217
Same Product Code
303
Applicant Total
3
Review Days
133
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Basic Information
- Device Name
- Us2.v1
- K Number
- K210791
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Eko.Ai Pte Ltd. D/B/A Us2.Ai
- Date Received
- March 16, 2021
- Decision Date
- July 27, 2021
- 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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