The following data is part of a premarket notification filed by Infinitt Co., Ltd. with the FDA for Infinitt Ulite.
| Device ID | K163290 |
| 510k Number | K163290 |
| Device Name: | INFINITT ULite |
| Classification | System, Image Processing, Radiological |
| Applicant | INFINITT CO., LTD. 12FI Daerung Post Tower III, 27 Digital-ro 34th Street Seoul, KR 152-746 |
| Contact | Heejin Lim |
| Correspondent | Carl Alletto OTech Inc. 8317 Belew Drive Mckinney, TX 75071 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-11-22 |
| Decision Date | 2017-03-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08809278790123 | K163290 | 000 |