FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
Topaz Mobile DR System
K Number: K183292
·
Decision May 15, 2019
Classifications
1
FEI Numbers
77
Registration Numbers
77
Same Product Code
235
Applicant Total
14
Review Days
170
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Basic Information
- Device Name
- Topaz Mobile DR System
- K Number
- K183292
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1720
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- DRGEM Corporation
- Date Received
- November 26, 2018
- Decision Date
- May 15, 2019
- Product Code
- IZL
- 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 |
|---|---|---|---|
| IZL | System, X-Ray, Mobile | FDA class 2 | Radiology |
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Other Clearances by DRGEM Corporation
| K Number | Device Name | ||
|---|---|---|---|
| K260085 | RAYMO Mobile X-ray System (Model: RAYMO) | May 14, 2026 | Substantially Equivalent |
| K251443 | PROMO | Aug 22, 2025 | Substantially Equivalent |
| K242019 | GXR-Series Diagnostic X-Ray System | Jan 7, 2025 | Substantially Equivalent |
| K242015 | TOPAZ Mobile X-ray System (Models : TOPAZ-32D, TOPAZ-40D) | Dec 16, 2024 | Substantially Equivalent |
| K232178 | GXR-ES/ECS Diagnostic X-Ray System, (Models GXR-ES series, GXR-ECS series) | Sep 19, 2023 | Substantially Equivalent |
| K202572 | GXR-Series Diagnostic X-Ray System | Sep 24, 2020 | Substantially Equivalent |
| K202156 | DIAMOND-5A/6A/8A | Sep 10, 2020 | Substantially Equivalent |
| 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 |