EchoPAC Software Only, EchoPAC Plug-In is an AI-enabled medical device from GE Medical Systems Ultrasound and Primary Care Diagnostics that the U.S. FDA cleared through 510(k) K200852 on September 18, 2020. Its lead review panel is Radiology and its primary product code is LLZ (System, Image Processing, Radiological).
See also FDA-cleared AI radiology devices in 2020, all FDA AI clearances in 2020, top radiology AI devices.
Key facts
| Submission number | K200852 |
|---|---|
| Pathway | 510(k) |
| Date of final decision | |
| Company (FDA list) | GE Medical Systems Ultrasound and Primary Care Diagnostics |
| Lead review panel | Radiology |
| Primary product code | LLZ — System, Image Processing, Radiological |
| Applicant (openFDA) | GE Medical Systems Ultrasound and Primary Care Diagnostics |
| Applicant location | Wauwatosa, WI, US |
| Device class | Class 2 |
| Regulation number | 21 CFR 892.2050 |
| 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. EchoPAC Software Only, EchoPAC Plug-In went through this pathway (K200852).
openFDA lists it as a Class 2 device under 21 CFR 892.2050. Class II devices are moderate risk and are subject to general and special controls.
Product code LLZ covers 161 devices on the FDA AI list. By decision date, this device is #78 of 161 under that code. GE Medical Systems Ultrasound and Primary Care Diagnostics has 31 AI-enabled devices on the list, and the Radiology panel accounts for 1,230 in total.
Being on this list doesn't describe how well the device works clinically. Check the FDA record for its indications for use.
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