The following data is part of a premarket notification filed by Medrad, Inc. with the FDA for Medrad Phased Array 1.5t Shoulder Imaging Surgace Coil.
Device ID | K964854 |
510k Number | K964854 |
Device Name: | MEDRAD PHASED ARRAY 1.5T SHOULDER IMAGING SURGACE COIL |
Classification | Coil, Magnetic Resonance, Specialty |
Applicant | MEDRAD, INC. 271 KAPPA DR. Pittsburgh, PA 15238 -2870 |
Contact | Rodney J Rylands |
Correspondent | Rodney J Rylands MEDRAD, INC. 271 KAPPA DR. Pittsburgh, PA 15238 -2870 |
Product Code | MOS |
CFR Regulation Number | 892.1000 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-12-03 |
Decision Date | 1997-02-11 |
Summary: | summary |