FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
uAI EasyTriage-Rib
K Number: K193271
·
Decision Jan 15, 2021
Classifications
1
FEI Numbers
22
Registration Numbers
22
Same Product Code
39
Applicant Total
4
Review Days
416
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Basic Information
- Device Name
- uAI EasyTriage-Rib
- K Number
- K193271
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2080
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Shanghai United Imaging Intelligence Co., Ltd.
- Date Received
- November 26, 2019
- Decision Date
- January 15, 2021
- Product Code
- QFM
- 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 |
|---|---|---|---|
| QFM | Radiological Computer-Assisted Prioritization Software For Lesions | FDA class 2 | Radiology |
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