The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc. with the FDA for Mi View&go.
Device ID | K201202 |
510k Number | K201202 |
Device Name: | MI View&GO |
Classification | System, Image Processing, Radiological |
Applicant | Siemens Medical Solutions USA, Inc. 2501 N Barrington Road Hoffman Estates, IL 60192 |
Contact | Clayton Ginn |
Correspondent | Clayton Ginn Siemens Medical Solutions USA, Inc. 2501 N Barrington Road Hoffman Estates, IL 60192 |
Product Code | LLZ |
CFR Regulation Number | 892.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2020-05-04 |
Decision Date | 2020-06-02 |