FDA 510(k)
FDA class 2
Substantially Equivalent
🇹🇼 Taiwan
BU-CAD
K Number: K210670
·
Decision Dec 21, 2021
Classifications
1
FEI Numbers
11
Registration Numbers
11
Same Product Code
34
Applicant Total
4
Review Days
291
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Basic Information
- Device Name
- BU-CAD
- K Number
- K210670
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2090
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Taihao Medical, Inc.
- Date Received
- March 5, 2021
- Decision Date
- December 21, 2021
- Product Code
- QDQ
- 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 |
|---|---|---|---|
| QDQ | Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer | FDA class 2 | Radiology |
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