The following data is part of a premarket notification filed by Douglas C. Yoon, Dds with the FDA for Dxs Digital X-ray System.
| Device ID | K013271 |
| 510k Number | K013271 |
| Device Name: | DXS DIGITAL X-RAY SYSTEM |
| Classification | System, X-ray, Extraoral Source, Digital |
| Applicant | DOUGLAS C. YOON, DDS 3940 LAUREL CANYON BLVD. #147 Studio City, CA 91604 |
| Contact | Douglas C Yoon |
| Correspondent | Douglas C Yoon DOUGLAS C. YOON, DDS 3940 LAUREL CANYON BLVD. #147 Studio City, CA 91604 |
| Product Code | MUH |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-10-01 |
| Decision Date | 2001-12-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D787XDRSW300 | K013271 | 000 |
| D787XDRSW1 | K013271 | 000 |
| D787215AC25B130A0 | K013271 | 000 |
| D787215AC25B11 | K013271 | 000 |
| D787213AC25B130A0 | K013271 | 000 |
| D787213AC25B11 | K013271 | 000 |
| D787XDR4P20ADSZ20 | K013271 | 000 |
| D787XDR4P10ACSZ10 | K013271 | 000 |