The following data is part of a premarket notification filed by Toshiba America Electronic Components, Inc. with the FDA for Digital X-ray Sensor, Model E9539,e9505,e9502, E9540.
| Device ID | K092537 |
| 510k Number | K092537 |
| Device Name: | DIGITAL X-RAY SENSOR, MODEL E9539,E9505,E9502, E9540 |
| Classification | System, X-ray, Extraoral Source, Digital |
| Applicant | TOSHIBA AMERICA ELECTRONIC COMPONENTS, INC. 2150 EAST LAKE COOK RD., SUITE 310 Buffalo Grove, IL 60089 |
| Contact | John Kurzydlo |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | MUH |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2009-08-19 |
| Decision Date | 2009-08-27 |
| Summary: | summary |