FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
PAPAYA 3D Premium & PAPAYA 3D Premium Plus
K Number: K200469
·
Decision Sep 16, 2020
Classifications
1
FEI Numbers
46
Registration Numbers
46
Same Product Code
133
Applicant Total
24
Review Days
203
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Basic Information
- Device Name
- PAPAYA 3D Premium & PAPAYA 3D Premium Plus
- K Number
- K200469
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1750
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Genoray Co., Ltd.
- Date Received
- February 26, 2020
- Decision Date
- September 16, 2020
- Product Code
- OAS
- 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 |
|---|---|---|---|
| OAS | X-Ray, Tomography, Computed, Dental | FDA class 2 | Radiology |
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