The following data is part of a premarket notification filed by Neusoft Medical Systems Co., Ltd. with the FDA for Positron Emission Tomography (pet) And Computed Tomography (ct) System, Positron Emission Tomography (pet) And Computed Tomography (ct) System.
| Device ID | K151403 |
| 510k Number | K151403 |
| Device Name: | Positron Emission Tomography (PET) And Computed Tomography (CT) System, Positron Emission Tomography (PET) And Computed Tomography (CT) System |
| Classification | System, Tomography, Computed, Emission |
| Applicant | NEUSOFT MEDICAL SYSTEMS CO., LTD. NO. 16, SHIJI ROAD HUNNAN INDUSTRIAL AREA Shenyang, CN 110179 |
| Contact | Tian Yuehui |
| Correspondent | Tian Yuehui NEUSOFT MEDICAL SYSTEMS CO., LTD. NO. 16, SHIJI ROAD HUNNAN INDUSTRIAL AREA Shenyang, 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 | 2015-05-26 |
| Decision Date | 2015-11-02 |
| Summary: | summary |