The following data is part of a premarket notification filed by Shimadzu Medical Systems with the FDA for Smt-100x/h And Smt-100x/x Magnetic Resonance Imaging System.
| Device ID | K932244 |
| 510k Number | K932244 |
| Device Name: | SMT-100X/H AND SMT-100X/X MAGNETIC RESONANCE IMAGING SYSTEM |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | SHIMADZU MEDICAL SYSTEMS 101 WEST WALNUT ST. Gardenia, CA 90248 |
| Contact | Kiyoshi Kume |
| Correspondent | Kiyoshi Kume SHIMADZU MEDICAL SYSTEMS 101 WEST WALNUT ST. Gardenia, CA 90248 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-05-10 |
| Decision Date | 1994-02-18 |