FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
Diagnostic X-ray System/PLX5200A
K Number: K212134
·
Decision Aug 25, 2021
Classifications
1
FEI Numbers
77
Registration Numbers
77
Same Product Code
235
Applicant Total
2
Review Days
48
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Basic Information
- Device Name
- Diagnostic X-ray System/PLX5200A
- K Number
- K212134
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1720
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Nanjing Perlove Medical Equipment Co., Ltd.
- Date Received
- July 8, 2021
- Decision Date
- August 25, 2021
- Product Code
- IZL
- 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 |
|---|---|---|---|
| IZL | System, X-Ray, Mobile | FDA class 2 | Radiology |
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Other Clearances by Nanjing Perlove Medical Equipment Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K243411 | Diagnostic X-ray System | May 19, 2025 | Substantially Equivalent |