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 |