MEDIP PRO is an AI-enabled medical device from MEDICALIP Co., Ltd that the U.S. FDA cleared through 510(k) K191026 on November 7, 2019. 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 2019, all FDA AI clearances in 2019, top radiology AI devices.
Key facts
| Submission number | K191026 |
|---|---|
| Pathway | 510(k) |
| Date of final decision | |
| Company (FDA list) | MEDICALIP Co., Ltd |
| Lead review panel | Radiology |
| Primary product code | LLZ — System, Image Processing, Radiological |
| Applicant (openFDA) | Medical IP Co., Ltd. |
| Applicant location | Jongno-Gu, KR |
| 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. MEDIP PRO went through this pathway (K191026).
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 #62 of 161 under that code. MEDICALIP Co., Ltd has 2 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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