The following data is part of a premarket notification filed by Neusoft Positron Medical Systems Co., Ltd with the FDA for Attrius, Model Pet150a6001, Attrius L, Model Pet150a8001, Truesight, Model Nsp-p6c, Truesight, Model Nsp-p8.
| Device ID | K090178 |
| 510k Number | K090178 |
| Device Name: | ATTRIUS, MODEL PET150A6001, ATTRIUS L, MODEL PET150A8001, TRUESIGHT, MODEL NSP-P6C, TRUESIGHT, MODEL NSP-P8 |
| Classification | System, Tomography, Computed, Emission |
| Applicant | NEUSOFT POSITRON MEDICAL SYSTEMS CO., LTD NO. 16M SHIJI ROAD HUNNAN NEW DISTRICT Shenyang, Liaoning, CN 110179 |
| Contact | Sun Yan |
| Correspondent | Sun Yan NEUSOFT POSITRON MEDICAL SYSTEMS CO., LTD NO. 16M SHIJI ROAD HUNNAN NEW DISTRICT Shenyang, Liaoning, CN 110179 |
| Product Code | KPS |
| CFR Regulation Number | 892.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-01-26 |
| Decision Date | 2009-04-24 |
| Summary: | summary |