FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
A1417MCW/A1717MCW/F1417MCW
K Number: K223930
·
Decision Mar 6, 2023
Classifications
1
FEI Numbers
126
Registration Numbers
126
Same Product Code
422
Applicant Total
4
Review Days
66
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Basic Information
- Device Name
- A1417MCW/A1717MCW/F1417MCW
- K Number
- K223930
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1680
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- H&abyz Co., Ltd.
- Date Received
- December 30, 2022
- Decision Date
- March 6, 2023
- Product Code
- MQB
- 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 |
|---|---|---|---|
| MQB | Solid State X-Ray Imager (Flat Panel/Digital Imager) | FDA class 2 | Radiology |
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