Edge Air(1417) Digital Flat Panel X-ray Detector
Osko, Inc.
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3010666400 | 3010666400 | OSKO,INC | 1 | Y | 2020-04-25 | 8085 NW 90th St Miami FL US 33166 |
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00869126000406 | RU3000 - Digital Diagnostic X-Ray System | +1(305)599-7161 | info@oskomedical.com |
| 00869126000413 | ELIAN - Digital Diagnostic X-Ray System | +1(305)599-7161 | info@oskomedical.com |
| 00869126000420 | XR5 - Diagnostic X-Ray System | +1(305)599-7161 | info@oskomedical.com |
| 00869126000437 | Edge - Digital Flat Panel X-Ray Detector used to generate images of any part of the body. The system consists of a scintillator directly coupled to an a-Si TFT sensor. The system generates high-resolution and high-sensitive digital images. | +1(305)599-7161 | info@oskomedical.com |
| 00869126000444 | Edge Air - Digital X-Ray flat panel detector used to acquire radiographic images of human anatomy when used with existing radiographic x-ray systems. | +1(305)599-7161 | info@oskomedical.com |
| 00869126000451 | Smart Stitching - A software application that allows post-capture positioning and joining of individual images, to produce an additional composite image for a two-dimensional image review. | +1(305)599-7161 | info@oskomedical.com |
| 00869126000468 | DCX - Stationary X-Ray System | +13055997161 | info@oskomedical.com |
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 167081 | 1122751196 | K200182 | EzRay Air Portable (Model: VEX-P300) | EHD | 2020-02-11 |
| 167081 | 1262956343 | K190866 | XmaruView V1 (Xmaru Chiroview, Xmaru Podview) | LLZ | 2019-04-30 |
| 167081 | 2040463923 | K172682 | Edge Digital Flat Panel X-ray Detector | MQB | 2017-10-06 |
| 167081 | 1650097018 | K172681 | Edge Air Digital Flat Panel X-ray Detector | MQB | 2017-10-06 |
| 167081 | 1893600010 | K171420 | 1717SCC_127um and 1717SCC_140um | MQB | 2017-06-09 |
| 167081 | 1853291164 | K171418 | 1417WCC_127um and1417WCC_140um | MQB | 2017-06-12 |
| 167081 | 2007738344 | K163048 | Smart Stitching Software System, Image Processing, Radiological | LLZ | 2017-07-28 |
| 167081 | 1630927029 | K162519 | 1717WCC / 1717WGC | MQB | 2016-10-06 |
| 167081 | 1464774590 | K162518 | 1012WCC, 1012WGC | MQB | 2016-10-06 |
| 167081 | 1217414348 | K161063 | EzRay Air (Model VEX-P300) | EHD | 2016-09-01 |
| 167081 | 1142249912 | K160579 | Xmaru View V1 and Xmaru PACS, Medical Image Processing Software | LLZ | 2016-04-08 |
| 167081 | 1861407232 | K150663 | Diagnostic X-ray System | KPR | 2015-05-07 |
| 167081 | 1031962585 | K150506 | ELIAN Digital Diagnostic X-ray System | KPR | 2015-04-08 |
| 167081 | 2017399705 | K141566 | SOLID STATE X-RAY IMAGING DEVICE, DIGIITAL FLAT PANEL X-RAY DETECTOR, 1417WCC | MQB | 2014-07-16 |
| 167081 | 1917867562 | K141563 | SOLID STATE X-RAY IMAGING DEVICE, DIGITAL FLAT PANEL X-RAY DETECTOR, 1417WGC | MQB | 2014-07-16 |
| 167081 | 1189658317 | K122182 | DIGITAL FLAT PANEL X-RAY DETECTOR/1717SGC | MQB | 2012-08-16 |
| 167081 | 1195030191 | ||||
| 167081 | 1199813975 | ||||
| 167081 | 1246177393 | ||||
| 167081 | 1333900687 | ||||
| 167081 | 1614969502 | ||||
| 167081 | 2059847696 |
Osko, Inc.
Osko, Inc.
OSKO, INC.
OSKO, INC.
OSKO, INC.
OSKO, INC.
2017-11-16
2019-06-10
2017-11-16
2017-11-16
2017-11-16
2017-11-16
2017-11-16