The following data is part of a premarket notification filed by Time Medical Limited with the FDA for Pica Whole Body Mri System Model Tms-mri-3500wb-01.
| Device ID | K093984 |
| 510k Number | K093984 |
| Device Name: | PICA WHOLE BODY MRI SYSTEM MODEL TMS-MRI-3500WB-01 |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | TIME MEDICAL LIMITED SUITE 5D,NO.19, LANE 999 ZHONGSHAN ROAD(S-2) Shanghai, CN 200030 |
| Contact | Diana Hong |
| Correspondent | Diana Hong TIME MEDICAL LIMITED SUITE 5D,NO.19, LANE 999 ZHONGSHAN ROAD(S-2) Shanghai, CN 200030 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-12-24 |
| Decision Date | 2010-03-24 |
| Summary: | summary |