System, X-Ray, Stationary
Regulation 892.1680
7510(k)s in 12 months (359 all time)
3recalls in 12 months (170 all time)
160recalls that name a 510(k)
Top companies in KPR
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 25, 2012 | K113855 | PANORAD, PANORAD SL Imix Adr Finland OY | KPR |
| Jan 17, 2012 | K113248 | AERODR SYSTEM WITH P-21 Konica Minolta Medical & Graphic, Inc. | KPR |
| Nov 30, 2011 | K111655 | FLAATZ 760 Drtech Corp., KR | KPR |
| Oct 27, 2011 | K112670 | DX-D 600 Agfa Healthcare N.V. | KPR |
| Aug 23, 2011 | K110828 | DDRELEMENT Swissray Medical AG | KPR |
| Aug 12, 2011 | K103448 | BRIVO XR385 Ge Medical Systems, LLC | KPR |
| May 16, 2011 | K101779 | CLEARVISION DR 2000 DIGITAL RADIOGRAPHY X-RAY SYSTEM Jpi Healthcare Co, Ltd., KR | KPR |
| Apr 26, 2011 | K110849 | PRESTODR 4143 Cmt Medical Technologies, Ltd., IL | KPR |
| Jan 24, 2011 | K102123 | VIZION DR Viztek, Inc. | KPR |
| Jan 3, 2011 | K102285 | KRYSTALRAD (ATAL8) Medicatech USA | KPR |
| Jan 3, 2011 | K102284 | KRYSTALRAD 560 (FLAATZ 560) Medicatech USA | KPR |
| Dec 27, 2010 | K102408 | DIGITAL DIAGNOSTIC X-RAY SYSTEM DRGEM Corporation | KPR |
| Nov 24, 2010 | K102349 | AERODR SYSTEM Konica Minolta Medical & Graphic, Inc. | KPR |
| Oct 29, 2010 | K103050 | DX-D 300 Agfa Healthcare N.V. | KPR |
| Oct 29, 2010 | K101686 | FDR IMAGE STITCHING OPTION Fujifilm Medical System U.S.A., Inc. | KPR |
| Oct 29, 2010 | K101042 | BLADEVIEW Accogent, LLC | KPR |
| Oct 22, 2010 | K102680 | Z-MOTION DIGITAL DIAGNOSTIC X-RAY SYSTEM Control-X Medical, Inc. | KPR |
| Oct 5, 2010 | K093816 | DIGITAL RADIOGRAPHY SYSTEM, MODELS GALAXY 900 AND 1600 Medien International Co, Ltd. | KPR |
| Sep 15, 2010 | K101435 | IMIX PANORAD AND SOMARAD Imix Adr Finland OY | KPR |
| Jul 21, 2010 | K092830 | DIGITAL X-RAY IMAGING SYSTEM, MODEL DRC-1000 VATECH Co., Ltd. | KPR |
| Nov 12, 2009 | K091752 | VIZTEK WL Viztek, Inc. | KPR |
| Aug 25, 2009 | K092307 | IMASIGHT 4600 DIGITAL RADIOGRAPHY SENSOR Imasight, Inc., CA | KPR |
| Jul 20, 2009 | K091889 | DRX-EVOLUTION, MODEL VX3733-SYS Carestream Health, Inc. | KPR |
| Jul 1, 2009 | K091747 | FLAATZ 500 Drtech Corp., KR | KPR |
| Jun 29, 2009 | K083640 | DIGITAL X-RAY IMAGING SYSTEM, MODEL: CXD-DR80D Choong Wae Medical Corp. | KPR |
| Mar 11, 2009 | K090279 | SEDECAL, MILLENNIUM PLUS Sedecal., Sa. | KPR |
| Feb 27, 2009 | K090238 | SEDECAL X-PLUS LP PLUS DIGITAL DIAGNOSTIC X-RAY SYSTEMS Sedecal., Sa. | KPR |
| Feb 13, 2009 | K083503 | DRAD30003/RADREX-I Toshiba America Medical Systems, In.C | KPR |
| Jan 8, 2009 | K083510 | KUBTEC XPERT 20 Kub Technologies, Inc. | KPR |
| Dec 4, 2008 | K083109 | SUINSA DIAGNOSTIC X-RAY SYSTEM Suinsa | KPR |
| Nov 26, 2008 | K083181 | QV-9000 UNIVERSAL SYSTEM Quantum Medical Imaging, LLC | KPR |
| Nov 21, 2008 | K082604 | VIZTEK DR, MODELS: DR1000, DR3000, DR4000 Viztek, Inc. | KPR |
| Nov 6, 2008 | K082261 | DXRAD MODELS DX800 OR DX808 DIGITAL DIAGNOSTIC RADIOGRAPHIC SYSTEMS Dxrad Solutions , Ltd. | KPR |
| Oct 28, 2008 | K082798 | DIGITAL DIAGNOSTIC X-RAY SYSTEM, MODELS MAK 1500, MAK 2000 AND MAK 3000 Medicatech USA | KPR |
| Aug 22, 2008 | K082064 | RADVISION ET DIAGNOSTIC X-RAY SYSTEM Almana Medical Imaging | KPR |
| Aug 22, 2008 | K081722 | YSIO Siemens Medical Solutions USA, Inc. | KPR |
| Jul 30, 2008 | K081836 | CARESTREAM DR LONG LENGTH IMAGING SYSTEM FOR DR 7500 SYSTEM Carestream Health, Inc. | KPR |
| Jun 20, 2008 | K080614 | DR VISION NEO, DR VISION DOU Almana Medical Imaging | KPR |
| May 15, 2008 | K080582 | MEDICATECH, MODEL DDR MAK-800, DDT MAK-1000 FS, DDR MAK-1100 FA Medicatech USA | KPR |
| May 9, 2008 | K080655 | CHRYSALIS Meta Imaging Solutions, LLC | KPR |
| Apr 16, 2008 | K080553 | DIGITAL RADIOGRAPHY SYSTEM, MODEL QXR-16 Vieworks Co., Ltd. | KPR |
| Feb 6, 2008 | K073650 | FUJIFILM UNITY SPEEDSUITE, MODEL CR-IR 371 Fujifilm Medical Systems U.S.A, Inc. | KPR |
| Jan 17, 2008 | K073114 | IMIX INSIGHT X-RAY SYSTEMS Imix Adr Finland OY | KPR |
| Jan 10, 2008 | K073632 | INTUITION, MODEL 0170 Arcoma AB, SE | KPR |
| Nov 21, 2007 | K072867 | IMIX 2000 DIGITAL RADIOGRAPHY SYSTEM, MODELS UNV 3K, UNV 3KW, UNV 4K Imix Adr Finland OY | KPR |
| Nov 15, 2007 | K072659 | RAD VISION, MODELS E AND EU Almana Medical Imaging | KPR |
| Sep 18, 2007 | K071546 | EOS Biospace Med | KPR |
| Aug 7, 2007 | K072010 | QUANTUM DIREX SYSTEM Quantum Medical Imaging, LLC | KPR |
| Aug 3, 2007 | K071392 | PXS-810, PODIATRY X-RAY SYSTEM Source-Ray, Inc. | KPR |
| Jun 22, 2007 | K071401 | X3C 2200 DIGITAL RADIOGRAPHIC SYSTEM Imaging Dynamics Company , Ltd., CA | KPR |
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