LVivo Software Application
by Dia Imaging Analysis, Ltd. 5 variants
510(k) K200232
LVivo Software Application is a medical device (FDA Class II; FDA product code QIH, Automated Radiological Image Processing Software) made by Dia Imaging Analysis, Ltd., cleared under FDA 510(k) K200232 on 23 Jun 2020, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK200232 | Date23 Jun 2020 | StatusActive |
Official records
- FDA 510(k) database K200232
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- QIH
- Device class
- Class II
- Regulation
- 21 CFR Part 892.2050
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
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