The following data is part of a premarket notification filed by Genoray Co., Ltd. with the FDA for Zenis, Picture Archiving And Communications System.
| Device ID | K103181 |
| 510k Number | K103181 |
| Device Name: | ZENIS, PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM |
| Classification | System, Image Processing, Radiological |
| Applicant | GENORAY CO., LTD. 1073 N, BATAVIA ST Orange, CA 92867 |
| Contact | Jae Kim |
| Correspondent | Jae Kim GENORAY CO., LTD. 1073 N, BATAVIA ST Orange, CA 92867 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-10-28 |
| Decision Date | 2011-08-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08809244060137 | K103181 | 000 |