The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc. with the FDA for Magnetom Vida.
Device ID | K170396 |
510k Number | K170396 |
Device Name: | MAGNETOM Vida |
Classification | System, Nuclear Magnetic Resonance Imaging |
Applicant | Siemens Medical Solutions USA, Inc. 65 Valley Stream Parkway Mailcode 65-1A Malvern, PA 19355 |
Contact | Cordell L. Fields, Esq. |
Correspondent | Cordell L. Fields, Esq. Siemens Medical Solutions USA, Inc. 65 Valley Stream Parkway Mailcode 65-1A Malvern, PA 19355 |
Product Code | LNH |
Subsequent Product Code | LNI |
Subsequent Product Code | MOS |
CFR Regulation Number | 892.1000 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-02-09 |
Decision Date | 2017-06-14 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
04056869053431 | K170396 | 000 |
04056869022956 | K170396 | 000 |
04056869022963 | K170396 | 000 |
04056869022970 | K170396 | 000 |
04056869023069 | K170396 | 000 |
04056869023076 | K170396 | 000 |
04056869023083 | K170396 | 000 |
04056869023090 | K170396 | 000 |
04056869023106 | K170396 | 000 |
04056869039176 | K170396 | 000 |
04056869044675 | K170396 | 000 |
04056869044682 | K170396 | 000 |
04056869044699 | K170396 | 000 |
04056869044705 | K170396 | 000 |
04056869044712 | K170396 | 000 |
04056869053424 | K170396 | 000 |
04056869022949 | K170396 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
MAGNETOM VIDA 79205326 5377429 Live/Registered |
Siemens Healthcare GmbH 2017-01-24 |