The following data is part of a premarket notification filed by Swissray Medical Ag with the FDA for Ddrcruze (digital Mobile Diagnostic X-ray System).
| Device ID | K131314 |
| 510k Number | K131314 |
| Device Name: | DDRCRUZE (DIGITAL MOBILE DIAGNOSTIC X-RAY SYSTEM) |
| Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
| Applicant | SWISSRAY MEDICAL AG TURBISTRASSE 25-27 Hochdorf, Lu, CH 6280 |
| Contact | Todd Shopp |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | MQB |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2013-05-07 |
| Decision Date | 2013-06-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860011334606 | K131314 | 000 |