FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
Xmaru View V1 and Xmaru PACS, Medical Image Processing Software
K Number: K160579
·
Decision Apr 8, 2016
Classifications
1
FEI Numbers
599
Registration Numbers
599
Same Product Code
2271
Applicant Total
38
Review Days
38
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Basic Information
- Device Name
- Xmaru View V1 and Xmaru PACS, Medical Image Processing Software
- K Number
- K160579
- 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
- March 1, 2016
- Decision Date
- April 8, 2016
- 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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| 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 |