The following data is part of a premarket notification filed by Shimadzu Medical Systems with the FDA for Smt-100x.
Device ID | K911975 |
510k Number | K911975 |
Device Name: | SMT-100X |
Classification | System, Nuclear Magnetic Resonance Imaging |
Applicant | SHIMADZU MEDICAL SYSTEMS 101 WEST WALNUT ST. Gardenia, CA 90248 |
Contact | De Mint |
Correspondent | De Mint 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 | 1991-05-03 |
Decision Date | 1991-10-30 |