The following data is part of a premarket notification filed by Infinitt Healthcare Co.,ltd. with the FDA for Infinitt Pacs 7.0.
| Device ID | K172803 |
| 510k Number | K172803 |
| Device Name: | Infinitt PACS 7.0 |
| Classification | System, Image Processing, Radiological |
| Applicant | Infinitt Healthcare Co.,Ltd. 12FI Daerung Post Tower III, 27 Digital-ro 34-gil Seoul, KR 08378 |
| Contact | Sang Wook Cho |
| Correspondent | Carl Alletto OTech Inc. 8317 Belew Drive Mckinney, TX 75071 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-18 |
| Decision Date | 2017-10-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08809278790130 | K172803 | 000 |