The following data is part of a premarket notification filed by Digimed Corporation with the FDA for Portable X-ray System.
| Device ID | K103600 |
| 510k Number | K103600 |
| Device Name: | PORTABLE X-RAY SYSTEM |
| Classification | Unit, X-ray, Extraoral With Timer |
| Applicant | DIGIMED CORPORATION 1607 N. BARCLAY AVE. Buffalo Grove, IL 60089 |
| Contact | Kim Antol |
| Correspondent | Kim Antol DIGIMED CORPORATION 1607 N. BARCLAY AVE. Buffalo Grove, IL 60089 |
| Product Code | EHD |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-12-08 |
| Decision Date | 2011-04-08 |
| Summary: | summary |