FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
Garion Image-Intensified Fluoroscopic X-Ray System, Mobile
K Number: K222080
·
Decision Oct 6, 2022
Classifications
1
FEI Numbers
118
Registration Numbers
118
Same Product Code
319
Applicant Total
3
Review Days
83
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Basic Information
- Device Name
- Garion Image-Intensified Fluoroscopic X-Ray System, Mobile
- K Number
- K222080
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1650
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sg Healthcare Co, Ltd.
- Date Received
- July 15, 2022
- Decision Date
- October 6, 2022
- 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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