The following data is part of a premarket notification filed by Neusoft Medical Systems Co., Ltd. with the FDA for Superstar 0.35t Mri System.
Device ID | K071154 |
510k Number | K071154 |
Device Name: | SUPERSTAR 0.35T MRI SYSTEM |
Classification | System, Nuclear Magnetic Resonance Imaging |
Applicant | NEUSOFT MEDICAL SYSTEMS CO., LTD. NO.3-11, WENHUA ROAD HEPING DISTRICT Shenyang, Liaoning, CN 110004 |
Correspondent | Tamas Borsai TUV RHEINLAND OF NORTH AMERICA, INC. 12 COMMERCE RD. Newton, CT 06470 |
Product Code | LNH |
CFR Regulation Number | 892.1000 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 2007-04-25 |
Decision Date | 2007-05-10 |
Summary: | summary |