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 |