Biograph Vision
System, Tomography, Computed, Emission
Siemens Medical Solutions USA, Inc.
The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc. with the FDA for Biograph Vision.
Pre-market Notification Details
| Device ID | K180811 |
| 510k Number | K180811 |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-03-29 |
| Decision Date | 2018-05-23 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04056869224503 | K180811 | 000 |
| 04056869183213 | K180811 | 000 |
Trademark Results [Biograph Vision]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 BIOGRAPH VISION 87590017 5710690 Live/Registered |
Siemens Medical Solutions USA, Inc. 2017-08-30 |
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