The following data is part of a premarket notification filed by Fmi Medical Systems Inc. with the FDA for Cura 16; Scintcare Ct16.
Device ID | K173076 |
510k Number | K173076 |
Device Name: | CURA 16; ScintCare CT16 |
Classification | System, X-ray, Tomography, Computed |
Applicant | FMI Medical Systems Inc. 29001 Solon Road, UnitA Solon, OH 44139 |
Contact | Scott Lemaster |
Correspondent | Paul Mcfeely FDA 510k Consultants, LLC 29001 Solon Road Unit A Solon, OH 44139 |
Product Code | JAK |
CFR Regulation Number | 892.1750 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-09-29 |
Decision Date | 2018-10-04 |
Summary: | summary |