The following data is part of a premarket notification filed by Siemens Medical Solutions, Inc. with the FDA for Arcadis Ordic (available With Options 3d And 3d Navigation Interface).
| Device ID | K042793 |
| 510k Number | K042793 |
| Device Name: | ARCADIS ORDIC (AVAILABLE WITH OPTIONS 3D AND 3D NAVIGATION INTERFACE) |
| Classification | Interventional Fluoroscopic X-ray System |
| Applicant | SIEMENS MEDICAL SOLUTIONS, INC. 51 VALLEY STREAM PARKWAY E-50 Malvern, PA 19355 |
| Contact | Debbie Peacock |
| Correspondent | Debbie Peacock SIEMENS MEDICAL SOLUTIONS, INC. 51 VALLEY STREAM PARKWAY E-50 Malvern, PA 19355 |
| Product Code | OWB |
| Subsequent Product Code | JAA |
| Subsequent Product Code | OXO |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-10-07 |
| Decision Date | 2004-10-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04056869009025 | K042793 | 000 |