The following data is part of a premarket notification filed by Shimadzu Medical Systems with the FDA for Smt-50cx/h.
| Device ID | K942669 |
| 510k Number | K942669 |
| Device Name: | SMT-50CX/H |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | SHIMADZU MEDICAL SYSTEMS 20101 SOUTH VERMONT AVE. Torrance, CA 90502 -1328 |
| Contact | Michael Fishback |
| Correspondent | Michael Fishback SHIMADZU MEDICAL SYSTEMS 20101 SOUTH VERMONT AVE. Torrance, CA 90502 -1328 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-06-06 |
| Decision Date | 1995-02-02 |