The following data is part of a premarket notification filed by Varian Medical Systems, X-ray Products-infimed with the FDA for Nexus Drf Digital X-ray Imaging System (with Paxscan 4343cb).
| Device ID | K130318 |
| 510k Number | K130318 |
| Device Name: | NEXUS DRF DIGITAL X-RAY IMAGING SYSTEM (WITH PAXSCAN 4343CB) |
| Classification | System, X-ray, Fluoroscopic, Image-intensified |
| Applicant | VARIAN MEDICAL SYSTEMS, X-RAY PRODUCTS-INFIMED 121 METROPOLITAN DR. Liverpool, NY 13088 |
| Contact | Catherine Mulcahy |
| Correspondent | Catherine Mulcahy VARIAN MEDICAL SYSTEMS, X-RAY PRODUCTS-INFIMED 121 METROPOLITAN DR. Liverpool, NY 13088 |
| Product Code | JAA |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-02-08 |
| Decision Date | 2013-04-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00854344007276 | K130318 | 000 |
| 00854344007634 | K130318 | 000 |
| 00854344007474 | K130318 | 000 |
| 00854344007245 | K130318 | 000 |
| 00854344007429 | K130318 | 000 |
| 00854344007443 | K130318 | 000 |
| 00854344007023 | K130318 | 000 |
| 00854344007054 | K130318 | 000 |
| 00854344007269 | K130318 | 000 |
| 00854344007610 | K130318 | 000 |