The following data is part of a premarket notification filed by Infinitt Co., Ltd. with the FDA for Reformat Gateway.
| Device ID | K052284 |
| 510k Number | K052284 |
| Device Name: | REFORMAT GATEWAY |
| Classification | System, Image Processing, Radiological |
| Applicant | INFINITT CO., LTD. 1600 MANCHESTER WAY Corinth, TX 76210 |
| Contact | Carl Alletto |
| Correspondent | Carl Alletto INFINITT CO., LTD. 1600 MANCHESTER WAY Corinth, TX 76210 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-08-22 |
| Decision Date | 2005-10-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08809278790048 | K052284 | 000 |