FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
AccuCheck
K Number: K223834
·
Decision Jul 20, 2023
Classifications
1
FEI Numbers
114
Registration Numbers
114
Same Product Code
733
Applicant Total
6
Review Days
210
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Basic Information
- Device Name
- AccuCheck
- K Number
- K223834
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.5050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Manteia Technologies Co., Ltd.
- Date Received
- December 22, 2022
- Decision Date
- July 20, 2023
- Product Code
- IYE
- 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 |
|---|---|---|---|
| IYE | Accelerator, Linear, Medical | FDA class 2 | Radiology |
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Other Clearances by Manteia Technologies Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K251351 | AccuContour 4.0 | Jan 23, 2026 | Substantially Equivalent |
| K250780 | ARTAssistant | Dec 5, 2025 | Substantially Equivalent |
| K250696 | AccuCheck | Oct 24, 2025 | Substantially Equivalent |
| K223724 | MOZI TPS | Jul 10, 2023 | Substantially Equivalent |
| K221706 | AccuContour | Mar 9, 2023 | Substantially Equivalent |