The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc. with the FDA for Arcadis Avantic.
| Device ID | K051133 |
| 510k Number | K051133 |
| Device Name: | ARCADIS AVANTIC |
| Classification | Image-intensified Fluoroscopic X-ray System, Mobile |
| Applicant | SIEMENS MEDICAL SOLUTIONS USA, INC. 51 VALLEY STREAM PARKWAY, E-50 Malvern, PA 19355 |
| Contact | Michael J Andrews |
| Correspondent | Michael J Andrews SIEMENS MEDICAL SOLUTIONS USA, INC. 51 VALLEY STREAM PARKWAY, E-50 Malvern, PA 19355 |
| Product Code | OXO |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-05-03 |
| Decision Date | 2005-06-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04056869009001 | K051133 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() ARCADIS AVANTIC 79011364 3083079 Live/Registered |
Siemens Healthcare GmbH 2005-05-06 |