The following data is part of a premarket notification filed by Suzhou Anke Medical System Co., Ltd with the FDA for Supervan 1.5t Magnetic Resonance Imaging System.
| Device ID | K131896 |
| 510k Number | K131896 |
| Device Name: | SUPERVAN 1.5T MAGNETIC RESONANCE IMAGING SYSTEM |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | SUZHOU ANKE MEDICAL SYSTEM CO., LTD P.O. BOX 120-119 Shanghai, CN 200120 |
| Contact | Diana Hong |
| Correspondent | Diana Hong SUZHOU ANKE MEDICAL SYSTEM CO., LTD P.O. BOX 120-119 Shanghai, CN 200120 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-06-25 |
| Decision Date | 2014-02-28 |
| Summary: | summary |