The following data is part of a premarket notification filed by Lg Electronics.inc with the FDA for X-clever.
| Device ID | K212137 |
| 510k Number | K212137 |
| Device Name: | X-Clever |
| Classification | System, Image Processing, Radiological |
| Applicant | LG Electronics.Inc 77, Sanho-Daero, Gyeongbuk Gumi-si, KR 39381 |
| Contact | Jin-hwan Jun |
| Correspondent | Bokyeong Kim GMS Consulting 4th Floor, Digital Cube, 34, Sangamsan-ro Seoul, KR 03909 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-07-08 |
| Decision Date | 2021-12-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00195174051306 | K212137 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() X-CLEVER 90794938 not registered Live/Pending |
LG ELECTRONICS INC. 2021-06-25 |