FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
DIAMOND-5A/6A/8A
K Number: K202156
·
Decision Sep 10, 2020
Classifications
1
FEI Numbers
81
Registration Numbers
81
Same Product Code
355
Applicant Total
14
Review Days
45
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Basic Information
- Device Name
- DIAMOND-5A/6A/8A
- K Number
- K202156
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 892.1680
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- DRGEM Corporation
- Date Received
- July 27, 2020
- Decision Date
- September 10, 2020
- 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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| K201124 | TOPAZ Mobile DR System | May 19, 2020 | Substantially Equivalent |
| K192453 | DIAMOND-5A/6A/8A | Oct 1, 2019 | Substantially Equivalent |
| K192364 | GXR-Series Diagnostic X-Ray System | Sep 26, 2019 | Substantially Equivalent |
| K183292 | Topaz Mobile DR System | May 15, 2019 | Substantially Equivalent |