The following data is part of a premarket notification filed by Mim Software Inc. with the FDA for Mim - Spectra Quant.
Device ID | K180815 |
510k Number | K180815 |
Device Name: | MIM - SPECTRA Quant |
Classification | System, Image Processing, Radiological |
Applicant | MIM Software Inc. 25800 Science Park Drive - Suite 180 Cleveland, OH 44122 |
Contact | Lynn Hanigan |
Correspondent | Lynn Hanigan MIM Software Inc. 25800 Science Park Drive - Suite 180 Cleveland, OH 44122 |
Product Code | LLZ |
CFR Regulation Number | 892.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2018-03-29 |
Decision Date | 2018-06-22 |
Summary: | summary |