The following data is part of a premarket notification filed by Dalian Senyint Digital Medical System Co., Ltd. with the FDA for Senyint Pacs.
| Device ID | K133098 |
| 510k Number | K133098 |
| Device Name: | SENYINT PACS |
| Classification | System, Image Processing, Radiological |
| Applicant | DALIAN SENYINT DIGITAL MEDICAL SYSTEM CO., LTD. 3500 SOUTH DUPONT HIGHWAY Dover, DE 19901 |
| Contact | Leon Lu |
| Correspondent | Leon Lu DALIAN SENYINT DIGITAL MEDICAL SYSTEM CO., LTD. 3500 SOUTH DUPONT HIGHWAY Dover, DE 19901 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-09-30 |
| Decision Date | 2014-06-13 |