FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
GC85A
K Number: K172229
·
Decision Nov 22, 2017
Classifications
1
FEI Numbers
81
Registration Numbers
81
Same Product Code
355
Applicant Total
40
Review Days
120
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Basic Information
- Device Name
- GC85A
- K Number
- K172229
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1680
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Samsung Electronics Co., Ltd.
- Date Received
- July 25, 2017
- Decision Date
- November 22, 2017
- Product Code
- KPR
- 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 |
|---|---|---|---|
| KPR | System, X-Ray, Stationary | FDA class 2 | Radiology |
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