The following data is part of a premarket notification filed by Digimed Corporation with the FDA for Portable X-ray System, Models Diox-602, Prox.
| Device ID | K082167 |
| 510k Number | K082167 |
| Device Name: | PORTABLE X-RAY SYSTEM, MODELS DIOX-602, PROX |
| Classification | Unit, X-ray, Extraoral With Timer |
| Applicant | DIGIMED CORPORATION 215 S. STATE STREET, STE 100B Salt Lake City, UT 84111 |
| Contact | Shin Kuk Yoo |
| Correspondent | Shin Kuk Yoo DIGIMED CORPORATION 215 S. STATE STREET, STE 100B Salt Lake City, UT 84111 |
| Product Code | EHD |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-07-31 |
| Decision Date | 2008-09-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800021800014 | K082167 | 000 |
| 78800021800006 | K082167 | 000 |