The following data is part of a premarket notification filed by Edge Medical Devices Ltd. with the FDA for Quix Digital Radiographic Upgrade.
| Device ID | K052661 |
| 510k Number | K052661 |
| Device Name: | QUIX DIGITAL RADIOGRAPHIC UPGRADE |
| Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
| Applicant | EDGE MEDICAL DEVICES LTD. 25 HATASIYA Raanana, IL 43654 |
| Contact | Vered Scharf |
| Correspondent | Vered Scharf EDGE MEDICAL DEVICES LTD. 25 HATASIYA Raanana, IL 43654 |
| Product Code | MQB |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-09-27 |
| Decision Date | 2006-06-07 |
| Summary: | summary |