Cios Alpha
Interventional Fluoroscopic X-ray System
Siemens Medical Systems USA, Inc.
The following data is part of a premarket notification filed by Siemens Medical Systems Usa, Inc. with the FDA for Cios Alpha.
Pre-market Notification Details
| Device ID | K181560 |
| 510k Number | K181560 |
| Device Name: | Cios Alpha |
| Classification | Interventional Fluoroscopic X-ray System |
| Applicant | Siemens Medical Systems USA, Inc. 40 Liberty Boulevard, 65-1A Malvern, PA 19355 |
| Contact | Patricia D. Jones |
| Correspondent | Patricia D. Jones Siemens Medical Systems 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 | 2018-06-14 |
| Decision Date | 2018-10-24 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04056869153490 | K181560 | 000 |
Trademark Results [Cios Alpha]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CIOS ALPHA 79130812 4434545 Live/Registered |
Siemens Healthcare GmbH 2013-02-20 |
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