The following data is part of a premarket notification filed by Radiographic Digital Imaging, Inc. with the FDA for Xscan32 Teleradiology Software.
| Device ID | K002911 |
| 510k Number | K002911 |
| Device Name: | XSCAN32 TELERADIOLOGY SOFTWARE |
| Classification | System, Image Processing, Radiological |
| Applicant | RADIOGRAPHIC DIGITAL IMAGING, INC. 1215 SOUTH ALAMEDA ST. Compton, CA 90220 |
| Contact | Stephen Neushul |
| Correspondent | Stephen Neushul RADIOGRAPHIC DIGITAL IMAGING, INC. 1215 SOUTH ALAMEDA ST. Compton, CA 90220 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-09-18 |
| Decision Date | 2001-06-07 |