AHI System is an AI-enabled medical device from Fifth Eye Inc. that the U.S. FDA cleared through 510(k) K212219 on December 3, 2021. Its lead review panel is Cardiovascular and its primary product code is QNV (Adjunctive Hemodynamic Indicator With Decision Point).
See also FDA-cleared AI cardiovascular devices in 2021, all FDA AI clearances in 2021, top cardiovascular AI devices.
Key facts
| Submission number | K212219 |
|---|---|
| Pathway | 510(k) |
| Date of final decision | |
| Company (FDA list) | Fifth Eye Inc. |
| Lead review panel | Cardiovascular |
| Primary product code | QNV — Adjunctive Hemodynamic Indicator With Decision Point |
| Applicant (openFDA) | Fifth Eye, Inc. |
| Applicant location | Ann Arbor, MI, US |
| Device class | Class 2 |
| Regulation number | 21 CFR 870.2220 |
| Decision code | SESE |
| Submission type | Traditional |
Source: FDA AI-Enabled Medical Devices list and openFDA.
What this means
A 510(k) is a premarket submission showing the device is substantially equivalent to a legally marketed predicate device. A cleared 510(k) means FDA agreed with that equivalence. AHI System went through this pathway (K212219).
openFDA lists it as a Class 2 device under 21 CFR 870.2220. Class II devices are moderate risk and are subject to general and special controls.
Product code QNV covers 3 devices on the FDA AI list. By decision date, this device is #2 of 3 under that code. Fifth Eye Inc. has 3 AI-enabled devices on the list, and the Cardiovascular panel accounts for 154 in total.
Being on this list doesn't describe how well the device works clinically. Check the FDA record for its indications for use.
Similar devices (product code QNV)
- AHI SystemFifth Eye Inc. · Cardiovascular
- Analytic for Hemodynamic Instability (AHI)Fifth Eye Inc. · Cardiovascular