LiverMultiScan (LMSv3)
FDA 510(k) clearance K190017 · decided 2019-06-27
Clearance details
- K-number
- K190017
- Device name
- LiverMultiScan (LMSv3)
- Applicant
- Perspectum Diagnostics, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2019-01-03
- Decision date
- 2019-06-27
- Days to decision
- 175 days
- Clearance type
- Traditional
- Product code
- LNH
- Device class
- 2
- Regulation number
- 892.1000
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Oxford, GB
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.