The following data is part of a premarket notification filed by Time Medical Limited with the FDA for Emma 1.5t Mri System.
| Device ID | K183621 |
| 510k Number | K183621 |
| Device Name: | EMMA 1.5T MRI System |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | Time Medical Limited G/F, Bio-Informatics Center No., 2 Science Park West Avenue Shatin, Nt, Hong Kong, CN |
| Contact | Nick Tse |
| Correspondent | Nick Tsc Time Medical Limited G/F, Bio-Informatics Center No., 2 Science Park West Avenue Shatin, N.t., Hong Kong, CN |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-12-26 |
| Decision Date | 2019-02-22 |
| Summary: | summary |