The following data is part of a premarket notification filed by Time Medical Limited with the FDA for Pica Whole Body Mri System.
| Device ID | K091580 |
| 510k Number | K091580 |
| Device Name: | PICA WHOLE BODY MRI SYSTEM |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | TIME MEDICAL LIMITED SUITE 8D,NO.19, LANE 999 ZHONGSHAN NO.2 ROAD(S) Shanghai, CN 200030 |
| Contact | Diana Hong |
| Correspondent | Morten S Christensen UNDERWRITERS LABORATORIES, INC. 455 E. TRIMBLE ROAD San Jose, CA 95131 -1230 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2009-06-02 |
| Decision Date | 2009-07-24 |
| Summary: | summary |