The following data is part of a premarket notification filed by Infinitt Company with the FDA for Infintt Co., Ltd. Starpacs System.
| Device ID | K031013 |
| 510k Number | K031013 |
| Device Name: | INFINTT CO., LTD. STARPACS SYSTEM |
| Classification | System, Image Processing, Radiological |
| Applicant | INFINITT COMPANY 1100 LAKEVIEW BLVD. Denton, TX 76208 |
| Contact | Carl Alletto |
| Correspondent | Carl Alletto INFINITT COMPANY 1100 LAKEVIEW BLVD. Denton, TX 76208 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-03-31 |
| Decision Date | 2003-04-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08809278790000 | K031013 | 000 |