The following data is part of a premarket notification filed by Varian Medical Systems, Inc. with the FDA for Paxscan 4030 Medical Digital Imaging System.
| Device ID | K024147 |
| 510k Number | K024147 |
| Device Name: | PAXSCAN 4030 MEDICAL DIGITAL IMAGING SYSTEM |
| Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
| Applicant | VARIAN MEDICAL SYSTEMS, INC. 3100 HANSEN WAY Palo Alto, CA 94304 |
| Contact | Linda S Nash |
| Correspondent | Linda S Nash VARIAN MEDICAL SYSTEMS, INC. 3100 HANSEN WAY Palo Alto, CA 94304 |
| Product Code | MQB |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-12-16 |
| Decision Date | 2003-02-12 |
| Summary: | summary |