510(k) K082167 ยท EHD Unit, X-Ray, Extraoral With Timer
PORTABLE X-RAY SYSTEM, MODELS DIOX-602, PROX
| Applicant | Digimed Corporation, Salt Lake City UT, US |
| Decision | Substantially Equivalent, Sep 26, 2008 |
| Received | Jul 31, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K082167
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 18, 2025 | DIGIMED CO., LTD Portable X-ray system Open, Classified |
EHD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.