510(k) K041050 ยท MUH System, X-Ray, Extraoral Source, Digital
DIGORA OPTIME (OR DIGORA ONTIME)
| Applicant | Soredex Palodex Group OY, Helsinki, FI |
| Decision | Substantially Equivalent, Jun 15, 2004 |
| Received | Apr 22, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K041050
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 7, 2020 | Palodex Group Oy Soredex DIGORA Optime SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER) Terminated |
MQB | None listed |
| Jan 7, 2020 | Palodex Group Oy Gendex GXPS-500 SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER) Terminated |
MQB | None listed |
| Jan 7, 2020 | Palodex Group Oy KaVo Scan eXam SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER) Terminated |
MQB | None listed |
| Jan 7, 2020 | Palodex Group Oy Instrumentarium Dental Express SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER) Terminated |
MQB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.