The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc. with the FDA for Artis Zee/zeego With Csx-10 Detector Sw Vc21.
| Device ID | K122644 |
| 510k Number | K122644 |
| Device Name: | ARTIS ZEE/ZEEGO WITH CSX-10 DETECTOR SW VC21 |
| Classification | Interventional Fluoroscopic X-ray System |
| Applicant | SIEMENS MEDICAL SOLUTIONS USA, INC. 51 VALLEY STREAM PKWY. Malvern, PA 19355 -1406 |
| Contact | Patricia D Jones |
| Correspondent | Patricia D Jones SIEMENS MEDICAL SOLUTIONS USA, INC. 51 VALLEY STREAM PKWY. Malvern, PA 19355 -1406 |
| Product Code | OWB |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-08-29 |
| Decision Date | 2013-05-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04056869010106 | K122644 | 000 |
| 04056869010090 | K122644 | 000 |
| 04056869010083 | K122644 | 000 |
| 04056869010076 | K122644 | 000 |
| 04056869010069 | K122644 | 000 |
| 04056869010052 | K122644 | 000 |
| 04056869010045 | K122644 | 000 |