The following data is part of a premarket notification filed by Shimadzu Medical Systems with the FDA for Smt-50a Magnetic Resonance Imaging System.
| Device ID | K893744 |
| 510k Number | K893744 |
| Device Name: | SMT-50A MAGNETIC RESONANCE IMAGING SYSTEM |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | SHIMADZU MEDICAL SYSTEMS C/O BIOMETRIC RESEARCH INST 1401 WILSON BOULEVARD, STE 400 Arlington, VA 22209 |
| Contact | Lynne Seekamp |
| Correspondent | Lynne Seekamp SHIMADZU MEDICAL SYSTEMS C/O BIOMETRIC RESEARCH INST 1401 WILSON BOULEVARD, STE 400 Arlington, VA 22209 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-05-18 |
| Decision Date | 1989-11-06 |