The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc. with the FDA for Biograph Vision.
Device ID | K190900 |
510k Number | K190900 |
Device Name: | Biograph Vision |
Classification | System, Tomography, Computed, Emission |
Applicant | Siemens Medical Solutions USA, Inc. 810 Innovation Drive Knoxville, TN 37932 |
Contact | Alaine Medio |
Correspondent | Alaine Medio Siemens Medical Solutions USA, Inc. 810 Innovation Drive Knoxville, TN 37932 |
Product Code | KPS |
CFR Regulation Number | 892.1200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2019-04-08 |
Decision Date | 2019-05-06 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
BIOGRAPH VISION 87590017 5710690 Live/Registered |
Siemens Medical Solutions USA, Inc. 2017-08-30 |