The following data is part of a premarket notification filed by Samsung Mobile Display Co., Ltd with the FDA for Digital Flat Panel X-ray Detector, Model Ltx240aa01-a.
| Device ID | K090742 |
| 510k Number | K090742 |
| Device Name: | DIGITAL FLAT PANEL X-RAY DETECTOR, MODEL LTX240AA01-A |
| Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
| Applicant | SAMSUNG MOBILE DISPLAY CO., LTD 256 NORTH SAM HOUSTON PKWY E #115 Houston, TX 77060 |
| Contact | Vincent Lee |
| Correspondent | Vincent Lee SAMSUNG MOBILE DISPLAY CO., LTD 256 NORTH SAM HOUSTON PKWY E #115 Houston, TX 77060 |
| Product Code | MQB |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-03-20 |
| Decision Date | 2009-09-18 |
| Summary: | summary |