FDA AI Clearance Tracker/K231207
Cardiovascular · 510(k)
CARTO 3 EP Navigation System Software V8.0 (FG-5400-00, FG-5400-00U)
Biosense Webster, Inc.
About this listing
CARTO 3 EP Navigation System Software V8.0 (FG-5400-00, FG-5400-00U) from Biosense Webster, Inc. appears on the U.S. FDA list of AI-enabled medical devices under submission K231207. It went through the 510(k) pathway, reviewed by the Cardiovascular panel, with an FDA decision dated September 7, 2023. Its primary FDA product code is DQK.
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
- CARTO 3 EP Navigation System Software V8.0 (FG-5400-00, FG-5400-00U)
- Company
- Biosense Webster, Inc.
- Submission number
- K231207
- Pathway
- 510(k)
- Decision date
- Sep 7, 2023
- Specialty (lead panel)
- Cardiovascular
- Primary product code
- DQK
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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.