The following data is part of a premarket notification filed by Portavision Medical Llc with the FDA for Neoray Dr 2520 Digital Imaging System.
| Device ID | K083048 |
| 510k Number | K083048 |
| Device Name: | NEORAY DR 2520 DIGITAL IMAGING SYSTEM |
| Classification | System, X-ray, Mobile |
| Applicant | PORTAVISION MEDICAL LLC 5401 COCOS PLUMOSAS DRIVE Kenner, LA 70065 |
| Contact | Terry Ancar |
| Correspondent | Terry Ancar PORTAVISION MEDICAL LLC 5401 COCOS PLUMOSAS DRIVE Kenner, LA 70065 |
| Product Code | IZL |
| CFR Regulation Number | 892.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-10-14 |
| Decision Date | 2008-11-21 |
| Summary: | summary |