The following data is part of a premarket notification filed by Mim Software Inc. with the FDA for Mim 5.2 (brachy).
Device ID | K103576 |
510k Number | K103576 |
Device Name: | MIM 5.2 (BRACHY) |
Classification | System, Image Processing, Radiological |
Applicant | MIM SOFTWARE INC. 25200 CHAGRIN BLVD. SUITE 200 Cleveland, OH 44122 |
Contact | Lynn Hanigan |
Correspondent | Lynn Hanigan MIM SOFTWARE INC. 25200 CHAGRIN BLVD. SUITE 200 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 | 2010-12-06 |
Decision Date | 2011-02-18 |
Summary: | summary |