Solid State X-Ray Imager (Flat Panel/Digital Imager)
Regulation 892.1680
3510(k)s in 12 months (424 all time)
2recalls in 12 months (195 all time)
193recalls that name a 510(k)
Top companies in MQB
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 16, 2015 | K152094 | GR40CW Samsung Electronics Co., Ltd., KR | MQB |
| Sep 10, 2015 | K152279 | ViZion DR + Wireless Viztek, LLC | MQB |
| Sep 8, 2015 | K141488 | CAREVIEW 1800R Careray Digital Medical System Co., Ltd. | MQB |
| Aug 4, 2015 | K150929 | CareView 1500Cw X-ray Flat Panel Detectors Careray Digital Medical System Co., Ltd., CN | MQB |
| Jul 13, 2015 | K151014 | Aura DR 43C-AG flat panel detector Abyzr Co., Ltd., KR | MQB |
| Jun 29, 2015 | K151465 | AeroDR SYSTEM 2 Konica Minolta, Inc., JP | MQB |
| Jun 24, 2015 | K150766 | Carestream DRX-1 System Carestream Health, Inc. | MQB |
| Jun 23, 2015 | K151221 | Kubtec DIGIVIEW 395 Kub Technologies, Inc. | MQB |
| Mar 27, 2015 | K150150 | 1717SGN / 1717SCN Digital Flat Panel X-ray Detector Rayence Co., Ltd., KR | MQB |
| Jan 30, 2015 | K143232 | Universal Digital Interface 2W, UDI 2W Meridian Medical Systems, LLC | MQB |
| Jan 23, 2015 | K143000 | RIS500 Ray Co., Ltd., KR | MQB |
| Jan 15, 2015 | K142475 | EVS 4343 DRTECH Corporation, KR | MQB |
| Dec 17, 2014 | K142718 | Radlink GPS Radlink, Inc. | MQB |
| Oct 23, 2014 | K142698 | PerkinElmer, XRpad 4343 F MED Flat Panel Detector Perkinelmer, Inc. | MQB |
| Oct 22, 2014 | K140251 | UNIVERSAL DIGITAL INTERFACE 2, UDI 2 Meridian Medical Systems, LLC | MQB |
| Oct 21, 2014 | K142003 | FDR D-EVO II FLAT PANEL DETECTOR SYSTEM Fujifilm Medical System U.S.A., Inc. | MQB |
| Oct 16, 2014 | K142184 | DX-D IMAGING PACKAGE Agfa Healthcare N.V. | MQB |
| Oct 3, 2014 | K141765 | FDR D-EVO FLAT PANEL DETECTOR SYSTEM Fujifilm Medical Systems U.S.A, Inc. | MQB |
| Oct 3, 2014 | K141743 | FUSION DIGITAL DIAGNOSTIC X-RAY UPGRADE KIT Radiology Solutions, LLC | MQB |
| Sep 26, 2014 | K141271 | AERODR SYSTEM 2 Konica Minolta, Inc. | MQB |
| Sep 12, 2014 | K141602 | DX-D IMAGING PACKAGE Agfa Healthcare N.V. | MQB |
| Aug 29, 2014 | K141440 | DICOMPACS DX-R WITH FLAT PANEL Oehm Und Rehbein GmbH | MQB |
| Aug 27, 2014 | K141435 | OPAL CHIRO, 20/20 P-DR 2020 Imaging | MQB |
| Aug 1, 2014 | K140551 | PERKINELMER, XRPAD 4336 MED FLAT PANEL DETECTOR Perkinelmer, Inc. | MQB |
| Jul 25, 2014 | K141736 | PHILIPS PROGRADE; PHILIPS ELEVA WORKSPOT FOR DIGITAL DIAGNOST Philips Medical Systems Dmc GmbH, DE | MQB |
| Jul 17, 2014 | K140825 | DELWORKS DR SYSTEM Del Medical, Inc. | MQB |
| Jul 16, 2014 | K141566 | SOLID STATE X-RAY IMAGING DEVICE, DIGIITAL FLAT PANEL X-RAY DETECTOR, 1417WCC Rayence Co., Ltd. | MQB |
| Jul 16, 2014 | K141563 | SOLID STATE X-RAY IMAGING DEVICE, DIGITAL FLAT PANEL X-RAY DETECTOR, 1417WGC Rayence Co., Ltd. | MQB |
| Jul 1, 2014 | K133693 | DIGITAL RADIOGRAPHY CXDI-401C WIRELESS Canon, Inc. | MQB |
| Jun 6, 2014 | K141192 | DR 400 Agfa Healthcare N.V. | MQB |
| May 15, 2014 | K140235 | XGEO GR40CW Samsung Electronics Co., Ltd., KR | MQB |
| May 13, 2014 | K140060 | DIGITAL DENTAL INTRA ORAL SENSOR, HDI 2000, HDI 2000A Rayence Co., Ltd. | MQB |
| May 13, 2014 | K140056 | DIGITAL DENTAL INTRA ORAL SENSOR; HDI 1000, HDI 1000A Rayence Co., Ltd. | MQB |
| Apr 25, 2014 | K140771 | PHILIPS ELEVA WORKSPOT Philips Medical Systems Dmc GmbH, DE | MQB |
| Apr 16, 2014 | K133524 | PVMED DDR 2430T Portavision Medical, LLC | MQB |
| Apr 11, 2014 | K140646 | DIGITAL FLAT PANEL X-RAY DETECTOR / 1717G, XMARU1717G Rayence Co., Ltd. | MQB |
| Apr 3, 2014 | K133139 | VIZION ULTRA Viztek, LLC | MQB |
| Mar 21, 2014 | K133782 | NOVA FA DR SYSTEM Sedecal., Sa. | MQB |
| Mar 11, 2014 | K133442 | BONE SUPPRESSION SOFTWARE Carestream Health, Inc. | MQB |
| Feb 21, 2014 | K133409 | DIGITAL FLAT PANEL X-RAY DETECTOR/ 910SGA Rayence Co., Ltd. | MQB |
| Feb 21, 2014 | K132842 | FLAATZ 600 SERIES (FLAATZ 600/601) Drtech Corp., KR | MQB |
| Jan 17, 2014 | K132921 | GALAXY PLUS Medien International Co, Ltd. | MQB |
| Jan 15, 2014 | K133120 | COMPUTED RADIOGRAPHY SCANNER 3Disc Americas | MQB |
| Jan 15, 2014 | K133106 | COMPUTED RADIOGRAPHY SCANNER 3Disc Americas | MQB |
| Nov 25, 2013 | K132509 | FDR D-EVO FLAT PANEL DETECTOR SYSTEM Fujifilm Medical Systems U.S.A, Inc. | MQB |
| Nov 5, 2013 | K131211 | DICOMPACS DX-R WITH FLAT PANEL Oehm Und Rehbein GmbH, DE | MQB |
| Oct 7, 2013 | K131483 | PHILIPS PIXIUM 4343RC Philips Medical Systems Dmc GmbH | MQB |
| Sep 17, 2013 | K131114 | DIGITAL FLAT PANEL X-RAY DETECTOR Rayence Co., Ltd. | MQB |
| Aug 29, 2013 | K131408 | CR 12-X DIGITIZER Agfa Healthcare N.V. | MQB |
| Aug 22, 2013 | K130936 | AERODR SYSTEM WITH P-31 Konica Minolta Medical & Graphic, Inc. | MQB |
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