FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
2430TCA with Xmaru W
K Number: K243849
·
Decision Mar 12, 2025
Classifications
1
FEI Numbers
40
Registration Numbers
40
Same Product Code
54
Applicant Total
38
Review Days
86
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Basic Information
- Device Name
- 2430TCA with Xmaru W
- K Number
- K243849
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 892.1715
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Rayence Co., Ltd.
- Date Received
- December 16, 2024
- Decision Date
- March 12, 2025
- Product Code
- MUE
- 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 |
|---|---|---|---|
| MUE | Full Field Digital, System, X-Ray, Mammographic | FDA class 2 | Radiology |
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Other Clearances by Rayence Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K242394 | Digital Flat Panel X-ray Detector (1717WCE, 1717WCE-HR, 1717WCE-HS, 1717WCE-GF) | Sep 9, 2024 | Substantially Equivalent |
| K240371 | 0909FCC, 0909FCC-HS | Mar 7, 2024 | Substantially Equivalent |
| K231467 | 1417WCE, 1417WCE-HR, 1417WCE-HS, 1417WCE-GF | Jun 21, 2023 | Substantially Equivalent |
| K220689 | Vatech Clismile | May 6, 2022 | Substantially Equivalent |
| K212753 | 0909FCB, 1212FCA | Oct 18, 2021 | Substantially Equivalent |
| K202902 | 2430MCA with Xmaru W | Jun 21, 2021 | Substantially Equivalent |
| K210985 | 1717FCC | Apr 28, 2021 | Substantially Equivalent |
| K202722 | 1212FCA | Oct 26, 2020 | Substantially Equivalent |
| K201796 | 1717SCV, 1717SGV | Jul 23, 2020 | Substantially Equivalent |
| K190866 | XmaruView V1 (Xmaru Chiroview, Xmaru Podview) | Apr 30, 2019 | Substantially Equivalent |