The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc. with the FDA for Artis Q And Q.zen- Modular Angiographic System.
| Device ID | K123529 |
| 510k Number | K123529 |
| Device Name: | ARTIS Q AND Q.ZEN- MODULAR ANGIOGRAPHIC SYSTEM |
| 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 |
| Subsequent Product Code | IZI |
| Subsequent Product Code | JAA |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-11-16 |
| Decision Date | 2013-02-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04056869010038 | K123529 | 000 |
| 04056869010021 | K123529 | 000 |
| 04056869010014 | K123529 | 000 |
| 04056869010007 | K123529 | 000 |
| 04056869009995 | K123529 | 000 |
| 04056869009988 | K123529 | 000 |
| 04056869009971 | K123529 | 000 |