FDA 510(k)
FDA class 2
Substantially Equivalent
🇬🇧 United Kingdom
LiverMultiScan
K Number: K202170
·
Decision Oct 2, 2020
Classifications
1
FEI Numbers
146
Registration Numbers
146
Same Product Code
1098
Applicant Total
5
Review Days
60
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Basic Information
- Device Name
- LiverMultiScan
- K Number
- K202170
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1000
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Perspectum, Ltd.
- Date Received
- August 3, 2020
- Decision Date
- October 2, 2020
- Product Code
- LNH
- 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 |
|---|---|---|---|
| LNH | System, Nuclear Magnetic Resonance Imaging | FDA class 2 | Radiology |
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