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 | K110942 |
| 510k Number | K110942 |
| Device Name: | PICA WHOLE-BODY MRI SYSTEM |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | TIME MEDICAL LIMITED NO. 2 SCIENCE PARK WEST AVE. SHATIN, NT Hong Kong, CN Ch |
| Contact | John Baby |
| Correspondent | John Baby TIME MEDICAL LIMITED NO. 2 SCIENCE PARK WEST AVE. SHATIN, NT Hong Kong, CN Ch |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-04-04 |
| Decision Date | 2011-07-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00862694000304 | K110942 | 000 |