About this listing
Hepatica v1 (Hepatica v1.0.0) from Perspectum Ltd. appears on the U.S. FDA list of AI-enabled medical devices under submission K203280. It went through the 510(k) pathway, reviewed by the Radiology panel, with an FDA decision dated January 12, 2021. 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
- Hepatica v1 (Hepatica v1.0.0)
- Company
- Perspectum Ltd.
- Submission number
- K203280
- Pathway
- 510(k)
- Decision date
- Jan 12, 2021
- Specialty (lead panel)
- Radiology
- Primary product code
- LNH
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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.