FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
XmaruView V1 (Xmaru Chiroview, Xmaru Podview)
K Number: K190866
·
Decision Apr 30, 2019
Classifications
1
FEI Numbers
609
Registration Numbers
609
Same Product Code
2221
Applicant Total
16
Review Days
27
Basic Information
- Device Name
- XmaruView V1 (Xmaru Chiroview, Xmaru Podview)
- K Number
- K190866
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Rayence Co., Ltd
- Date Received
- April 3, 2019
- Decision Date
- April 30, 2019
- Product Code
- LLZ
- 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 |
|---|---|---|---|
| LLZ | System, Image Processing, Radiological | FDA class 2 | Radiology |
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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 |
| 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 |
| K171418 | 1417WCC_127um and1417WCC_140um | Jun 12, 2017 | Substantially Equivalent |
| K171417 | 1417WGC_127um and 1417WGC_140um | Jun 12, 2017 | Substantially Equivalent |