The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc. with the FDA for Symbia Va10a Family.
Device ID | K212604 |
510k Number | K212604 |
Device Name: | Symbia VA10A Family |
Classification | System, Tomography, Computed, Emission |
Applicant | Siemens Medical Solutions USA, Inc. 810 Innovation Drive Knoxville, TN 37932 |
Contact | Tabitha Estes |
Correspondent | Tabitha Estes 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 | 2021-08-17 |
Decision Date | 2021-09-16 |