LiverMultiScan (v6.0)
FDA 510(k) K253413 · Perspectum, Ltd.
510(k) numberK253413
Submission
- Device name
- LiverMultiScan (v6.0)
- Applicant
- Perspectum, Ltd.
Oxford, GB - Received
- October 1, 2025
- Decision date
- March 9, 2026
- 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 (v6.0) cleared by the FDA?
LiverMultiScan (v6.0) (K253413) received a 510(k) decision of Substantially Equivalent on March 9, 2026, 159 days after the submission was received.
What is the product code of K253413?
The FDA product code is LNH – System, Nuclear Magnetic Resonance Imaging, a Class II (moderate risk) device regulated under 21 CFR 892.1000.