LiverMultiScan
FDA 510(k) K172685 · Perspectum Diagnostics, Ltd.
510(k) numberK172685
Submission
- Device name
- LiverMultiScan
- Applicant
- Perspectum Diagnostics, Ltd.
Oxford, GB - Received
- September 6, 2017
- Decision date
- November 21, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was LiverMultiScan cleared by the FDA?
LiverMultiScan (K172685) received a 510(k) decision of Substantially Equivalent on November 21, 2017, 76 days after the submission was received.
What is the product code of K172685?
The FDA product code is LNH – System, Nuclear Magnetic Resonance Imaging, a Class II (moderate risk) device regulated under 21 CFR 892.1000.