FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇱 Israel
LVivo Software Application
K Number: K200232
·
Decision Jun 23, 2020
Classifications
1
FEI Numbers
217
Registration Numbers
217
Same Product Code
303
Applicant Total
10
Review Days
145
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Basic Information
- Device Name
- LVivo Software Application
- K Number
- K200232
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Dia Imaging Analysis, Ltd.
- Date Received
- January 30, 2020
- Decision Date
- June 23, 2020
- Product Code
- QIH
- 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 |
|---|---|---|---|
| QIH | Automated Radiological Image Processing Software | FDA class 2 | Radiology |
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Other Clearances by Dia Imaging Analysis, Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K243862 | LVivo Software Application | Mar 17, 2025 | Substantially Equivalent |
| K243331 | LVivo Seamless | Mar 6, 2025 | Substantially Equivalent |
| K243235 | LVivo Software Application | Mar 3, 2025 | Substantially Equivalent |
| K240553 | LVivo Software Application | Oct 4, 2024 | Substantially Equivalent |
| K240769 | LVivo IQS | May 24, 2024 | Substantially Equivalent |
| K222970 | LVivo IQS | Feb 1, 2023 | Substantially Equivalent |
| K212466 | LVivo Seamless | Dec 9, 2021 | Substantially Equivalent |
| K210053 | LVivo Software Application | Feb 5, 2021 | Substantially Equivalent |
| K202546 | LVivo Seamless | Sep 29, 2020 | Substantially Equivalent |