VISENSIA is an AI-enabled medical device from OBS MEDICAL that the U.S. FDA cleared through 510(k) K081140 on July 17, 2008. Its lead review panel is Cardiovascular and its primary product code is MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)).
See also top cardiovascular AI devices.
Key facts
| Submission number | K081140 |
|---|---|
| Pathway | 510(k) |
| Date of final decision | |
| Company (FDA list) | OBS MEDICAL |
| Lead review panel | Cardiovascular |
| Primary product code | MHX — Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) |
| Applicant (openFDA) | Obs Medical |
| Applicant location | Carmel, IN, US |
| Device class | Class 2 |
| Regulation number | 21 CFR 870.1025 |
| 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. VISENSIA went through this pathway (K081140).
openFDA lists it as a Class 2 device under 21 CFR 870.1025. Class II devices are moderate risk and are subject to general and special controls.
Product code MHX covers 3 devices on the FDA AI list. By decision date, this device is #1 of 3 under that code. OBS MEDICAL has 1 AI-enabled device 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.