The following data is part of a premarket notification filed by Neusoft Medical Systems Co., Ltd. with the FDA for Beyondimage Workstation.
| Device ID | K092235 |
| 510k Number | K092235 |
| Device Name: | BEYONDIMAGE WORKSTATION |
| Classification | System, Image Processing, Radiological |
| Applicant | NEUSOFT MEDICAL SYSTEMS CO., LTD. NO. 16, SHIJI ROAD HUNNAN INDUSRTIAL AREA Shenyang, Liaoning, CN 110179 |
| Contact | Tian Yuehui |
| Correspondent | Tamas Borsai TUV RHEINLAND OF NORTH AMERICA, INC. 12 COMMERCE RD. Newton, CT 06470 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2009-07-23 |
| Decision Date | 2009-08-06 |
| Summary: | summary |