FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
2430MCA with Xmaru W
K Number: K202902
·
Decision Jun 21, 2021
Classifications
1
FEI Numbers
40
Registration Numbers
40
Same Product Code
54
Applicant Total
38
Review Days
265
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- 2430MCA with Xmaru W
- K Number
- K202902
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1715
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Rayence Co., Ltd.
- Date Received
- September 29, 2020
- Decision Date
- June 21, 2021
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MUE), ordered by most recent decision date.
MAMMOMAT B.brilliant (11372950)
FDA 510(k)
FDA Class 2
·Radiology
Bellalun 2D (VDMS-1000S)
FDA 510(k)
FDA Class 2
·Radiology
Senographe Pristina; SenoBright HD; Pristina Serena; Pristina Serena Bright
FDA 510(k)
FDA Class 2
·Radiology
HESTIA
FDA 510(k)
FDA Class 2
·Radiology
2430TCA with Xmaru W
FDA 510(k)
FDA Class 2
·Radiology
VIVIX-M
FDA 510(k)
FDA Class 2
·Radiology
Other Clearances by Rayence Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K243849 | 2430TCA with Xmaru W | Mar 12, 2025 | Substantially Equivalent |
| 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 |
| 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 |