The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc. with the FDA for Multix Impact.
Device ID | K203345 |
510k Number | K203345 |
Device Name: | MULTIX Impact |
Classification | System, X-ray, Stationary |
Applicant | Siemens Medical Solutions USA, Inc. 40 Liberty Blvd Mail Code: 65-1A Malvern, PA 19355 |
Contact | Martin Rajchel |
Correspondent | Martin Rajchel Siemens Medical Solutions USA, Inc. 40 Liberty Blvd Mail Code: 65-1A Malvern, PA 19355 |
Product Code | KPR |
CFR Regulation Number | 892.1680 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2020-11-13 |
Decision Date | 2021-01-07 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
MULTIX IMPACT 79255719 5911313 Live/Registered |
Siemens Healthcare GmbH 2018-12-10 |