ARTIS Pheno
Interventional Fluoroscopic X-ray System
SIEMENS MEDICAL SOLUTION USA, INC.
The following data is part of a premarket notification filed by Siemens Medical Solution Usa, Inc. with the FDA for Artis Pheno.
Pre-market Notification Details
| Device ID | K163286 |
| 510k Number | K163286 |
| Device Name: | ARTIS Pheno |
| Classification | Interventional Fluoroscopic X-ray System |
| Applicant | SIEMENS MEDICAL SOLUTION USA, INC. 40 LIBERTY BOULEVARD 65-1A Malvern, PA 19355 |
| Contact | Patricia D. Jones |
| Correspondent | Patricia D. Jones SIEMENS MEDICAL SOLUTION USA, INC. 40 LIBERTY BOULEVARD 65-1A Malvern, PA 19355 |
| Product Code | OWB |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-11-22 |
| Decision Date | 2017-03-09 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04056869046877 | K163286 | 000 |
Trademark Results [ARTIS Pheno]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ARTIS PHENO 79204552 5388868 Live/Registered |
Siemens Healthcare GmbH 2017-01-02 |
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