FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
COMPUTED TOMOGRAPHY X-RAY SYSTEM
K Number: K102196
·
Decision Mar 25, 2011
Classifications
1
FEI Numbers
46
Registration Numbers
46
Same Product Code
133
Applicant Total
40
Review Days
239
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Basic Information
- Device Name
- COMPUTED TOMOGRAPHY X-RAY SYSTEM
- K Number
- K102196
- 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
- July 29, 2010
- Decision Date
- March 25, 2011
- Product Code
- OAS
- 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 |
|---|---|---|---|
| OAS | X-Ray, Tomography, Computed, Dental | FDA class 2 | Radiology |
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Other Clearances by VATECH Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
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| K243088 | Green X 12 SE (PHT-40CHS) | Feb 21, 2025 | Substantially Equivalent |
| K243081 | Green X 21 (PHT-90CHO) | Feb 14, 2025 | Substantially Equivalent |
| K240040 | VistaPano S Ceph 2.0 (VistaPano S Ceph); VistaPano S 2.0 (VistaPano S); ProVecta S-Pan Ceph 2.0 (ProVecta S-Pan Ceph); ProVecta S-Pan 2.0 (ProVecta S-Pan) | Oct 25, 2024 | Substantially Equivalent |
| K231796 | Grreen X 12 (Model: PHT-75CHS) | Jul 19, 2023 | Substantially Equivalent |
| K223058 | EzRay Air 2 Wall (Model: VEX-S350W) | Oct 26, 2022 | Substantially Equivalent |
| K213462 | EzRay M18 (Model: VMX-P400) | Feb 11, 2022 | Substantially Equivalent |
| K210329 | Green X 18(Model : PHT-75CHS) | Feb 18, 2021 | Substantially Equivalent |
| K203667 | EzRay M (Model: VMX-P300) | Feb 2, 2021 | Substantially Equivalent |
| K203797 | vatech A9 (Model : PHT-30CSS) | Jan 25, 2021 | Substantially Equivalent |