FDA Product Code
FDA Product Code MQB — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Radiology
- 21 CFR Citation
- 892.1680
510(k) Clearances — 424 records · page 3 of 5
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K152094 | GR40CW | Samsung Electronics Co., Ltd. | 2015-10-16 | Traditional | PDF ↗ |
| K152279 | ViZion DR + Wireless | Viztek, LLC | 2015-09-10 | Special | PDF ↗ |
| K141488 | CAREVIEW 1800R | Careray Digital Medical System Co., Ltd. | 2015-09-08 | Traditional | PDF ↗ |
| K150929 | CareView 1500Cw X-ray Flat Panel Detectors | Careray Digital Medical System Co., Ltd. | 2015-08-04 | Traditional | PDF ↗ |
| K151014 | Aura DR 43C-AG flat panel detector | Abyzr Co., Ltd. | 2015-07-13 | Traditional | PDF ↗ |
| K151465 | AeroDR SYSTEM 2 | Konica Minolta, Inc. | 2015-06-29 | Special | PDF ↗ |
| K150766 | Carestream DRX-1 System | Carestream Health, Inc. | 2015-06-24 | Traditional | PDF ↗ |
| K151221 | Kubtec DIGIVIEW 395 | Kub Technologies, Inc. | 2015-06-23 | Traditional | PDF ↗ |
| K150150 | 1717SGN / 1717SCN Digital Flat Panel X-ray Detector | Rayence Co., Ltd. | 2015-03-27 | Traditional | PDF ↗ |
| K143232 | Universal Digital Interface 2W, UDI 2W | Meridian Medical Systems, LLC | 2015-01-30 | Special | PDF ↗ |
| K143000 | RIS500 | Ray Co., Ltd. | 2015-01-23 | Traditional | PDF ↗ |
| K142475 | EVS 4343 | DRTECH Corporation | 2015-01-15 | Traditional | PDF ↗ |
| K142718 | Radlink GPS | Radlink, Inc. | 2014-12-17 | Traditional | PDF ↗ |
| K142698 | PerkinElmer, XRpad 4343 F MED Flat Panel Detector | Perkinelmer, Inc. | 2014-10-23 | Special | PDF ↗ |
| K140251 | UNIVERSAL DIGITAL INTERFACE 2, UDI 2 | Meridian Medical Systems, LLC | 2014-10-22 | Traditional | PDF ↗ |
| K142003 | FDR D-EVO II FLAT PANEL DETECTOR SYSTEM | Fujifilm Medical System U.S.A., Inc. | 2014-10-21 | Traditional | PDF ↗ |
| K142184 | DX-D IMAGING PACKAGE | Agfa Healthcare N.V. | 2014-10-16 | Traditional | PDF ↗ |
| K141765 | FDR D-EVO FLAT PANEL DETECTOR SYSTEM | Fujifilm Medical Systems U.S.A, Inc. | 2014-10-03 | Traditional | PDF ↗ |
| K141743 | FUSION DIGITAL DIAGNOSTIC X-RAY UPGRADE KIT | Radiology Solutions, LLC | 2014-10-03 | Traditional | PDF ↗ |
| K141271 | AERODR SYSTEM 2 | Konica Minolta, Inc. | 2014-09-26 | Traditional | PDF ↗ |
| K141602 | DX-D IMAGING PACKAGE | Agfa Healthcare N.V. | 2014-09-12 | Traditional | PDF ↗ |
| K141440 | DICOMPACS DX-R WITH FLAT PANEL | Oehm Und Rehbein GmbH | 2014-08-29 | Traditional | PDF ↗ |
| K141435 | OPAL CHIRO, 20/20 P-DR | 2020 Imaging | 2014-08-27 | Traditional | PDF ↗ |
| K140551 | PERKINELMER, XRPAD 4336 MED FLAT PANEL DETECTOR | Perkinelmer, Inc. | 2014-08-01 | Traditional | PDF ↗ |
| K141736 | PHILIPS PROGRADE; PHILIPS ELEVA WORKSPOT FOR DIGITAL DIAGNOST | Philips Medical Systems Dmc GmbH | 2014-07-25 | Special | PDF ↗ |
| K140825 | DELWORKS DR SYSTEM | Del Medical, Inc. | 2014-07-17 | Traditional | PDF ↗ |
| K141566 | SOLID STATE X-RAY IMAGING DEVICE, DIGIITAL FLAT PANEL X-RAY DETECTOR, 1417WCC | Rayence Co., Ltd. | 2014-07-16 | Special | PDF ↗ |
| K141563 | SOLID STATE X-RAY IMAGING DEVICE, DIGITAL FLAT PANEL X-RAY DETECTOR, 1417WGC | Rayence Co., Ltd. | 2014-07-16 | Special | PDF ↗ |
| K133693 | DIGITAL RADIOGRAPHY CXDI-401C WIRELESS | Canon, Inc. | 2014-07-01 | Traditional | PDF ↗ |
| K141192 | DR 400 | Agfa Healthcare N.V. | 2014-06-06 | Traditional | PDF ↗ |
| K140235 | XGEO GR40CW | Samsung Electronics Co., Ltd. | 2014-05-15 | Traditional | PDF ↗ |
| K140056 | DIGITAL DENTAL INTRA ORAL SENSOR; HDI 1000, HDI 1000A | Rayence Co., Ltd. | 2014-05-13 | Special | PDF ↗ |
| K140060 | DIGITAL DENTAL INTRA ORAL SENSOR, HDI 2000, HDI 2000A | Rayence Co., Ltd. | 2014-05-13 | Special | PDF ↗ |
| K140771 | PHILIPS ELEVA WORKSPOT | Philips Medical Systems Dmc GmbH | 2014-04-25 | Special | PDF ↗ |
| K133524 | PVMED DDR 2430T | Portavision Medical, LLC | 2014-04-16 | Traditional | PDF ↗ |
| K140646 | DIGITAL FLAT PANEL X-RAY DETECTOR / 1717G, XMARU1717G | Rayence Co., Ltd. | 2014-04-11 | Special | PDF ↗ |
| K133139 | VIZION ULTRA | Viztek, LLC | 2014-04-03 | Special | PDF ↗ |
| K133782 | NOVA FA DR SYSTEM | Sedecal., Sa. | 2014-03-21 | Special | PDF ↗ |
| K133442 | BONE SUPPRESSION SOFTWARE | Carestream Health, Inc. | 2014-03-11 | Traditional | PDF ↗ |
| K133409 | DIGITAL FLAT PANEL X-RAY DETECTOR/ 910SGA | Rayence Co., Ltd. | 2014-02-21 | Special | PDF ↗ |
| K132842 | FLAATZ 600 SERIES (FLAATZ 600/601) | Drtech Corp. | 2014-02-21 | Special | PDF ↗ |
| K132921 | GALAXY PLUS | Medien International Co, Ltd. | 2014-01-17 | Traditional | PDF ↗ |
| K133120 | COMPUTED RADIOGRAPHY SCANNER | 3Disc Americas | 2014-01-15 | Special | PDF ↗ |
| K133106 | COMPUTED RADIOGRAPHY SCANNER | 3Disc Americas | 2014-01-15 | Special | PDF ↗ |
| K132509 | FDR D-EVO FLAT PANEL DETECTOR SYSTEM | Fujifilm Medical Systems U.S.A, Inc. | 2013-11-25 | Traditional | PDF ↗ |
| K131211 | DICOMPACS DX-R WITH FLAT PANEL | Oehm Und Rehbein GmbH | 2013-11-05 | Traditional | PDF ↗ |
| K131483 | PHILIPS PIXIUM 4343RC | Philips Medical Systems Dmc GmbH | 2013-10-07 | Traditional | PDF ↗ |
| K131114 | DIGITAL FLAT PANEL X-RAY DETECTOR | Rayence Co., Ltd. | 2013-09-17 | Traditional | PDF ↗ |
| K131408 | CR 12-X DIGITIZER | Agfa Healthcare N.V. | 2013-08-29 | Special | PDF ↗ |
| K130936 | AERODR SYSTEM WITH P-31 | Konica Minolta Medical & Graphic, Inc. | 2013-08-22 | Traditional | PDF ↗ |
| K131106 | DIGITAL RADIOGRAPHY CXDI-701C WIRELESS, DIGITAL RADIOGRAPHY CXDI-70IG WIRELESS, DIGITAL RADIOGRAPHY CXDI-801C WIRELESS, | Canon, Inc. | 2013-07-03 | Traditional | PDF ↗ |
| K130935 | DIGITAL FLAT PANEL X-RAY DETECTOR/1417WCA | Rayence Co., Ltd. | 2013-07-02 | Traditional | PDF ↗ |
| K131314 | DDRCRUZE (DIGITAL MOBILE DIAGNOSTIC X-RAY SYSTEM) | Swissray Medical AG | 2013-06-25 | Traditional | PDF ↗ |
| K130567 | DR LONG LENGTH IMAGING SOFTWARE | Carestream Health, Inc. | 2013-06-11 | Traditional | PDF ↗ |
| K130464 | CARESTREAM DRX-1 SYSTEM WITH DRX 2530C DETECTOR | Carestream Health, Inc. | 2013-06-07 | Traditional | PDF ↗ |
| K130377 | KRYSTALRAD NEW SERIESDIGITAL RADIOGRAPHIC PORTABLE RETROFIT SYSTEM | Medicatech USA | 2013-05-17 | Special | PDF ↗ |
| K130883 | SEDECAL DIGITAL RADIOGRAPHIC UPGRADE MODEL SDRU-T | Sedecal., Sa. | 2013-04-18 | Traditional | PDF ↗ |
| K123345 | DIGITAL FLAT PANEL X-RAY DETECTOR / 1012WCA | Rayence Co., Ltd. | 2013-03-12 | Traditional | PDF ↗ |
| K122736 | DX-D IMAGING PACKAGE | Agfa Healthcare N.V. | 2013-03-11 | Traditional | PDF ↗ |
| K123740 | EOS | Eos Imaging | 2013-02-22 | Special | PDF ↗ |
| K122865 | VIVIX-S WIRELESS | Vieworks Co., Ltd. | 2013-02-01 | Traditional | PDF ↗ |
| K122928 | DIGITAL FLAT PANEL X-RAY DETECTOR/1417PGA | Rayence Co., Ltd. | 2013-01-30 | Traditional | PDF ↗ |
| K123644 | VIZION + DR | Viztek, LLC | 2013-01-11 | Special | PDF ↗ |
| K122866 | VIVIX-S WITH VXVUE | Vieworks Co., Ltd. | 2013-01-11 | Traditional | PDF ↗ |
| K122919 | DIGITAL FLAT PANEL X-RAY DETECTOR11417PCA | Rayence Co., Ltd. | 2013-01-01 | Traditional | PDF ↗ |
| K123499 | AEROPILOT | Konica Minolta Medical & Graphic, Inc. | 2012-12-20 | Traditional | PDF ↗ |
| K123005 | DDRVERSA MOTION | Swissray Medical AG | 2012-12-07 | Special | PDF ↗ |
| K122495 | PERKINELMER XRD 1622 AP3 MED FLAT PANEL DETECTOR | Perkinelmer, Inc. | 2012-11-28 | Traditional | PDF ↗ |
| K122173 | DIGITAL FLAT PLANEL X-RAY DETECTOR / 1717SCC | Rayence Co., Ltd. | 2012-10-19 | Special | PDF ↗ |
| K122842 | RADREX-I, SW V4.00 MODEL DRAD-3000E | Toshiba America Medical Systems, In.C | 2012-10-09 | Special | PDF ↗ |
| K120629 | FDR GO FLEX | Fujifilm Medical System U.S.A., Inc. | 2012-08-28 | Special | PDF ↗ |
| K121095 | DX-D IMAGING PACKAGE | Agfa Healthcare N.V. | 2012-08-16 | Traditional | PDF ↗ |
| K122182 | DIGITAL FLAT PANEL X-RAY DETECTOR/1717SGC | Rayence Co., Ltd. | 2012-08-16 | Special | PDF ↗ |
| K121948 | CR 10-X DIGITIZER | Agfa Healthcare N.V. | 2012-07-20 | Special | PDF ↗ |
| K121838 | LIEBEL-FLARSHEIM DIRECT DIGITAL IMAGING SYSTEM | Liebel-Flarsheim | 2012-07-11 | Traditional | PDF ↗ |
| K113449 | FUSION FLAT PANEL | Icrco, Inc. | 2012-06-14 | Traditional | PDF ↗ |
| K112527 | UNIVERSAL DIGITAL INTERFACE (UDI) 1717 | Meridian Medical Systems, LLC | 2012-05-22 | Traditional | PDF ↗ |
| K121132 | EZSENSOR P DIGITAL INTRAORAL SENSOR | Humanray Co,Ltd | 2012-05-10 | Special | PDF ↗ |
| K120020 | VIVIX-S | Vieworks Co., Ltd. | 2012-05-04 | Traditional | PDF ↗ |
| K113812 | ATAL-8 | Atlaim | 2012-05-03 | Traditional | PDF ↗ |
| K111824 | FLAT PANEL DETECTOR | Canon Inc. -Medical Equipment Group | 2012-04-23 | Traditional | PDF ↗ |
| K102327 | CLEARVISION DR 7000F | Jpi Healthcare Co, Ltd. | 2012-04-13 | Traditional | PDF ↗ |
| K120477 | AEROSYNC FOR AERODR SYSTEM | Konica Minolta Medical & Graphic, Inc. | 2012-04-09 | Traditional | PDF ↗ |
| K120721 | EOS | Eos Imaging | 2012-04-06 | Special | PDF ↗ |
| K120380 | SATURN 8000 | New Medical Co., Ltd. | 2012-03-09 | Traditional | PDF ↗ |
| K120131 | REGIUS SIGMA2 | Konica Minolta Medical & Graphic, Inc. | 2012-02-10 | Special | PDF ↗ |
| K111305 | UNIVERSAL DIGITAL INTERFACE WIRELESS - UDI 1417W | Meridian Medical Systems, LLC | 2012-01-31 | Traditional | PDF ↗ |
| K113630 | DIGITAL FLAT PANEL X-RAY DETECTOR/1210SGA | Rayence Co., Ltd. | 2011-12-29 | Special | PDF ↗ |
| K112751 | SDX-4343CS | Samsung Mobile Display Co., Ltd. | 2011-11-23 | Special | PDF ↗ |
| K113052 | INFINIX-CCI | Toshiba America Medical Systems, In.C | 2011-11-22 | Special | PDF ↗ |
| K112132 | KRYSTALRAD 660 DIGITAL RADIOGRAPHIC PORTABLE RETROFIT SYSTEM | Medicatech USA | 2011-11-18 | Traditional | PDF ↗ |
| K112558 | DIGITAL FLAT PANEL X-RAY DETECTOR | Samsung Mobile Display Co., Ltd. | 2011-11-10 | Special | PDF ↗ |
| K103348 | DIGIVIEW 250 | Kub Technologies, Inc. | 2011-10-20 | Traditional | PDF ↗ |
| K112661 | VIZION DR | Viztek, LLC | 2011-10-20 | Special | PDF ↗ |
| K111583 | FLAATZ 560 | Drtech Corp. | 2011-10-04 | Special | PDF ↗ |
| K111865 | WIRED/ WIRELESS FDR D-EVO WITH X-RAY DETECTION FEATURE | Fujifilm Medical System U.S.A., Inc. | 2011-09-30 | Traditional | PDF ↗ |
| K112309 | DIGITAL RADIOGRAPHY | Canon Inc. -Medical Equipment Group | 2011-09-02 | Special | PDF ↗ |
| K111682 | DIGITAL RADIOGRAPHY | Canon Inc. -Medical Equipment Group | 2011-09-02 | Special | PDF ↗ |
| K111548 | WIRELESS/WIRED FDR D-EVO FLAT PANCEL DETECTOR SYSTEM MODEL DR-ID600 W/DR-ID611SE | Fujifilm Medical System U.S.A., Inc. | 2011-08-30 | Traditional | PDF ↗ |
| K110801 | WV3000T DIGITAL X-RAY DIRECT IMAGING FLAT PANEL DETECTOR SYSTEM | Direct Digital Imaging Technology (Beijing), Inc. | 2011-08-02 | Special | PDF ↗ |
Product code MQB · Class II · Radiology. Data: openFDA.