SPECTRALMD DEEPVIEW WOUND IMAGING SYSTEM 2.0 is an AI-enabled medical device from SPECTRALMD, INC. that the U.S. FDA cleared through 510(k) K163339 on August 17, 2017. Its lead review panel is Cardiovascular and its primary product code is DPT (Probe, Blood-Flow, Extravascular).
See also FDA-cleared AI cardiovascular devices in 2017, all FDA AI clearances in 2017, top cardiovascular AI devices.
Key facts
| Submission number | K163339 |
|---|---|
| Pathway | 510(k) |
| Date of final decision | |
| Company (FDA list) | SPECTRALMD, INC. |
| Lead review panel | Cardiovascular |
| Primary product code | DPT — Probe, Blood-Flow, Extravascular |
| Applicant (openFDA) | Spectralmd, Inc. |
| Applicant location | Dallas, TX, US |
| Device class | Class 2 |
| Regulation number | 21 CFR 870.2120 |
| 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. SPECTRALMD DEEPVIEW WOUND IMAGING SYSTEM 2.0 went through this pathway (K163339).
openFDA lists it as a Class 2 device under 21 CFR 870.2120. Class II devices are moderate risk and are subject to general and special controls.
Product code DPT covers 1 device on the FDA AI list. By decision date, this device is #1 of 1 under that code. SPECTRALMD, INC. has 2 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.