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 |
|---|---|---|---|
| Jul 13, 2011 | K111312 | SANTEVIEW Sehyun Co., Ltd. | MQB |
| Jun 2, 2011 | K103703 | REGUIS SIGMA Konica Minolta Medical & Graphic, Inc. | MQB |
| Jun 2, 2011 | K102479 | ALARA T210 COMPUTED RADIOGRAPHY SYSTEM Alara, Inc. | MQB |
| May 27, 2011 | K111098 | INNOVAXION FP, INNOVAXION FP 1600 PLUS, MAGELLAN Imaging Dynamics Company , Ltd. | MQB |
| May 13, 2011 | K102619 | COMPUTED RADDIOGRAPHY SCANNER 3Disc Americas | MQB |
| Apr 27, 2011 | K103599 | UNIVERSAL DIGITAL INTERFACE (UDI) 1717 Meridian Medical Systems, LLC | MQB |
| Apr 20, 2011 | K110210 | SATURN 8000-GS New Medical Co., Ltd. | MQB |
| Mar 29, 2011 | K103596 | WIRELESS/WIRED FDR D-EVO FLAT PANEL DETECTOR Fujifilm Medical Systems U.S.A, Inc. | MQB |
| Mar 29, 2011 | K103591 | DIGITAL RADIOGRAPHY Canon Inc. -Medical Equipment Group, JP | MQB |
| Mar 4, 2011 | K102474 | FLAATZ 750E Drtech Corp., KR | MQB |
| Feb 11, 2011 | K102321 | DIGITAL FLAT PANEL X-RAY DETECTOR MODEL SDX-4336CP Samsung Mobile Display Co., Ltd. | MQB |
| Dec 21, 2010 | K100703 | STATIONARY X-RAY SYSTEM (DETECTOR) MODEL: ALTAS Comed Co., Ltd. | MQB |
| Dec 1, 2010 | K102587 | LLX240AB01 Samsung Mobile Display Co., Ltd. | MQB |
| Nov 29, 2010 | K101590 | DIGITAL FLAT PANEL X-RAY DETECTOR VATECH Co., Ltd. | MQB |
| Nov 18, 2010 | K102615 | WIRELESS DR IMAGING OPTION-WDR1 Ge Medical Systems, LLC | MQB |
| Aug 17, 2010 | K102012 | DIGITAL RADIOGRAPHY Canon Inc. -Medical Equipment Group, JP | MQB |
| Aug 9, 2010 | K091090 | DIGITAL FLAT PANEL X-RAY DETECTOR, MODEL XMARU 1717 E-Woo Technology | MQB |
| Aug 3, 2010 | K101289 | SCANX D5000 SERIES SCANNER MODEL: D5000-F, D5000-FB, D5000-FVB, D5000-Q, D5000-QB Air Techniques, Inc. | MQB |
| Jul 15, 2010 | K100762 | FLAT PANEL DETECTOR, MODEL FDR D-EVO Fujifilm Medical Systems U.S.A, Inc. | MQB |
| Jun 25, 2010 | K100001 | MOBIVISION Almana Medical Imaging | MQB |
| Apr 5, 2010 | K093790 | SIMONDR DRP Simondr, Inc. | MQB |
| Jan 21, 2010 | K093427 | FDR ACSELERATE SYSTEM, DR-ID 200 FLAT PANEL DETECTOR Fujifilm Medical System U.S.A., Inc. | MQB |
| Nov 6, 2009 | K092669 | DX-D IMAGING PACKAGE Agfa Healthcare N.V., BE | MQB |
| Oct 30, 2009 | K092717 | DIRECT DIGITIZER, REGIUS MODEL 210 Konica Minolta Medical & Graphic, Inc. | MQB |
| Sep 18, 2009 | K090742 | DIGITAL FLAT PANEL X-RAY DETECTOR, MODEL LTX240AA01-A Samsung Mobile Display Co., Ltd. | MQB |
| Aug 11, 2009 | K092238 | AGFA COMPUTED RADIOGRAPHY SYSTEMS WITH DX-G DIGITIZERS Agfa Healthcare N.V., BE | MQB |
| Jun 30, 2009 | K082450 | IDR Icrco, Inc. | MQB |
| Jun 15, 2009 | K091545 | DIGITAL RADIOGRAPHY CXDI-60C Canon, Inc. | MQB |
| May 29, 2009 | K091436 | DIGITAL RADIOGRAPHY, MODEL CXDI-55C Canon, Inc. | MQB |
| May 29, 2009 | K091435 | DIGITAL RADIOGRAPHY MODEL CXDI-55G Canon, Inc. | MQB |
| May 18, 2009 | K090672 | AGFA COMPUTED RADIOGRAPHY SYSTEMS WITH NX WORKSTATIONS Agfa Healthcare N.V., BE | MQB |
| May 18, 2009 | K090062 | WV1417A DIGITAL X-RAY DIRECT IMAGING FLAT PANEL DETECTOR SYSTEM Direct Digital Imaging Technology (Beijing), Inc., CN | MQB |
| Apr 6, 2009 | K090318 | CARESTREAM DRX-1 SYSTEM Carestream Health, Inc. | MQB |
| Mar 24, 2009 | K090625 | WIRELESS PORTABLE DETECTOR FD-W17 Philips Medical Systems North America Co. | MQB |
| Mar 24, 2009 | K090623 | DIGITAL RADIOGRAPHY CXDI-40G COMPACT Canon USA, Inc. | MQB |
| Mar 24, 2009 | K083224 | CPI RAD VISION, MODEL VZW2944XX-YY Communications & Power Industries Canada, Inc., CA | MQB |
| Feb 24, 2009 | K083645 | RADSTAR FAMILY, MODELS: RADSTAR 4343 & VARIATIONS 5 Star Medical, Inc. | MQB |
| Nov 18, 2008 | K082347 | DIGITAL RADIOGRAPHY, FLEXDR C30 Konica Minolta Technoproduct Co., Ltd. | MQB |
| Sep 12, 2008 | K082494 | DRAD3000E/RADREX-I Toshiba America Medical Systems, In.C | MQB |
| Jul 25, 2008 | K081963 | AGFA COMPUTED RADIOGRAPHY SYSTEMS WITH NX2008 WORKSTATIONS Agfa Healthcare Corporation | MQB |
| Jun 24, 2008 | K081648 | DIGITAL RADIOGRAPHY CXDI-60G Canon, Inc. | MQB |
| Jun 23, 2008 | K081624 | INFX-8000F (INFINIX CSI AND INFINIX DPI) Toshiba America Medical Systems, In.C | MQB |
| Jun 11, 2008 | K080589 | SATURN 9000-810 New Medical Co., Ltd., TW | MQB |
| Jan 25, 2008 | K073670 | KODAK POINT OF CARE CR 120, KODAK POINT OF CARE CR 140, KODAK POINT OF CARE CR 260 Orex Computed Radiography, Ltd., IL | MQB |
| Jan 23, 2008 | K080064 | FLAATZ 750 Drtech Corp., KR | MQB |
| Nov 16, 2007 | K073165 | DRAD-3000E, RADREX-I Toshiba America Medical Systems, In.C | MQB |
| Nov 14, 2007 | K072984 | SATURN 9000-550 New Medical Co., Ltd., TW | MQB |
| Nov 13, 2007 | K073056 | DIGITAL RADIOGRAPHY SYSTEM, MODEL: QXR-9 Vieworks Co., Ltd., KR | MQB |
| Nov 13, 2007 | K072983 | SATURN 9000-750 New Medical Co., Ltd., TW | MQB |
| Aug 15, 2007 | K071682 | CRYSTALVIEW T-SERIES COMPUTED RADIOGRAPHY SYSTEM, MODELS T110 (WITH ERASER) AND T100 (WITHOUT ERASER) Alara, Inc. | MQB |
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