FDA AI Clearance Tracker/K202170

Radiology · 510(k)

LiverMultiScan

Perspectum LTD

About this listing

LiverMultiScan from Perspectum LTD appears on the U.S. FDA list of AI-enabled medical devices under submission K202170. It went through the 510(k) pathway, reviewed by the Radiology panel, with an FDA decision dated October 2, 2020. Its primary FDA product code is LNH.

The FDA list records the regulatory facts above. For the device's cleared intended use, read the FDA decision summary linked at the bottom of this page.

Device
LiverMultiScan
Company
Perspectum LTD
Submission number
K202170
Pathway
510(k)
Decision date
Oct 2, 2020
Specialty (lead panel)
Radiology
Primary product code
LNH

More Radiology AI devices

Source: U.S. FDA AI-Enabled Medical Devices list. The FDA says the list is not comprehensive. Confirm details on the FDA's own record.