FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DENTAL COMPUTED TOMOGRAPHY X-RAY SYSTEM
K Number: K102259
·
Decision Feb 18, 2011
Classifications
1
FEI Numbers
163
Registration Numbers
163
Same Product Code
818
Applicant Total
40
Review Days
192
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Basic Information
- Device Name
- DENTAL COMPUTED TOMOGRAPHY X-RAY SYSTEM
- K Number
- K102259
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1750
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- VATECH Co., Ltd.
- Date Received
- August 10, 2010
- Decision Date
- February 18, 2011
- Product Code
- JAK
- 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 |
|---|---|---|---|
| JAK | System, X-Ray, Tomography, Computed | FDA class 2 | Radiology |
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| K223058 | EzRay Air 2 Wall (Model: VEX-S350W) | Oct 26, 2022 | Substantially Equivalent |
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| K210329 | Green X 18(Model : PHT-75CHS) | Feb 18, 2021 | Substantially Equivalent |
| K203667 | EzRay M (Model: VMX-P300) | Feb 2, 2021 | Substantially Equivalent |
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