FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
Diagnostic X-ray System
K Number: K243411
·
Decision May 19, 2025
Classifications
1
FEI Numbers
118
Registration Numbers
118
Same Product Code
319
Applicant Total
2
Review Days
199
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Basic Information
- Device Name
- Diagnostic X-ray System
- K Number
- K243411
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1650
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Nanjing Perlove Medical Equipment Co., Ltd.
- Date Received
- November 1, 2024
- Decision Date
- May 19, 2025
- Product Code
- OWB
- 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 |
|---|---|---|---|
| OWB | Interventional Fluoroscopic X-Ray System | FDA class 2 | Radiology |
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Other Clearances by Nanjing Perlove Medical Equipment Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K212134 | Diagnostic X-ray System/PLX5200A | Aug 25, 2021 | Substantially Equivalent |