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Panels › Radiology › Product code MQB · Class 2

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)
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Top companies in MQB

DateFirm and productCodeLinked 510(k)
Dec 11, 2017Philips Electronics North America Corporation
digital x-ray detector ProGrade R1 - solid state X ray imager (flat panel/digital imager) As a part of a radiographic system, the Philips ProGrade is intended to acquire, process, store, display, an
Terminated
MQBK141736
May 11, 2017Philips Electronics North America Corporation
Philips DigitalDiagnost 3.1.x X-Ray System
Terminated
MQBK141736
Mar 23, 2017Toshiba American Medical Systems
Toshiba Medical Radrex - i Digital Radiography X-ray system Radrex-i is intended for use in conjunction with the ceiling suspended tube support, high voltage generator, and bucky stand or bucky tab
Terminated
MQBK122842
Feb 27, 2017LIEBEL-FLARSHEIM COMPANY LLC
Liebel-Flarsheim Direct Digital Imaging System (DDIS) Liebel-Flarsheim urology systems facilitate radiologic and/or fluoroscopic procedures requiring a beam of diagnostic quality radiation, primaril
Terminated
MQBK121838
Dec 21, 2016AGFA Healthcare Corp.
Agfa Healthcare NX 3.0.8950 Imaging Processing Software
Terminated
MQBK090672
Jun 3, 2016Philips Healthcare
Philips Healthcare DigitalDiagnost stationary X-ray system
Terminated
MQBK141736
May 19, 2015Philips Medical Systems, Inc.
Philips Healthcare DigitalDiagnost System X-Ray
Terminated
MQBK141736
May 5, 2015Eos Imaging Inc
EOS, Digital radiography system used in general radiographic examinations.
Terminated
MQBK123740
Mar 23, 2015Philips Electronics North America Corporation
Philips DigitalDiagnost Release 4.0.3, Release 4.1/4.1.1. excluding systems with SP1 Product Usage: The DigitalDiagnost is intended for use in generating radiographic images of human anatomy by qual
Terminated
MQBK141736
Jun 4, 2014Toshiba American Medical Systems Inc
Toshiba Infinix X-Ray Interventional System INFX-8000V/UU. An X-Ray system that is capable of radiographic and fluoroscopic studies used in an interventional setting.
Terminated
MQBK120073
Apr 24, 2014Philips Medical Systems, Inc.
Digital Diagnost, stationary radiographic system; Models: 712020/22/25/26/50/52/54/55/57/60/62/80/81/82/85
Terminated
MQBK982795
Feb 24, 2014GE Healthcare, LLC
GE Healthcare Precision 500D and Proteus XR/a equipped with Wireless Digital Radiography Option (WDR1). The Wireless DR Imaging Option ( WDR1), when used with a radiographic imaging system, is indict
Terminated
MQBK102615
Jan 9, 2014EOS Imaging
EOS System X- ray beam Digital radiography system used in general radiographic examinations.
Terminated
MQBNone listed
Dec 27, 2013Philips Medical Systems, Inc.
Philips Essenta DR, a Stationary x-ray system, X-ray system Model: 712070 The Essenta DR is a multifunctional stationary X-ray system, in which the swivel arm rotation, the vertical movement of the
Terminated
MQBK070528
Nov 7, 2013Carestream Health Inc.
CARESTREAM DRX -Mobile Retrofit Kit, Catalog number: 1019397. Made in U.S.A. by Carestream Health, Inc. 150 Verona Street Rochester, NY 14608 to perform radiographic x-ray examinations on all pediat
Terminated
MQBK090318
Jul 24, 2013Siemens Medical Solutions USA, Inc
Axiom Aristos MX Solid State Flat Panel Digital Imager, Model number 5895003. The device is used for diagnostic X-ray imaging.
Terminated
MQBK983732
Jun 17, 2013Philips Healthcare Inc.
Philips Diagnost Stationary Radiographic System Models: 712020, 712022, 712050, 712052, 712055, 712057, 712062 Product Usage: Universal RAD Applications
Terminated
MQBK982795
Jun 17, 2013Philips Healthcare Inc.
Philips Diagnost Stationary Radiographic System Models: 712020, 712022, 712050, 712052, 712055, 712057, 712062 Product Usage: Universal RAD Applications
Terminated
MQBK982795
Apr 3, 2013Cooper Surgical, Inc.
LEEP REDIKIT Product No. 6060 In a Loop Electrosurgical Excision Procedure, a thin, low-voltage electrified wire loop is used to cut out abnormal cervical tissue. The cartridges of Polocaine and
Terminated
MQBK910253
Mar 25, 2013Toshiba American Medical Systems Inc
Toshiba Infinix-i X-Ray System. A radiographic and fluoroscopic x-ray system for use in diagnostic and angiographic procedures.
Terminated
MQBK052884
K081624 +2
Mar 19, 2013AGFA Corp.
CR MD1.0 General Set, x-ray imager image plate. CR 10-X Image Plate 35CM X 43CM. An image plate, contained in an X-Ray cassette, used to capture images from X-Ray exposures. The cassette with the im
Terminated
MQBK121948
Mar 13, 2013GE Healthcare, LLC
GE Healthcare Advantx, Innova2000, Innova3100, Innova4100, Innova2100IQ, Innova3100IQ, and Innova4100IQ equipped with Video Monitor Suspension Cardiovascular X-ray imaging systems. Model numbers 2236
Terminated
MQBK023178
K031637 +4
Mar 11, 2013GE Healthcare, LLC
GE Healthcare, Innova 2100 IQ, Innova 3100 IQ, Innova 4100 IQ. Cardiovascular X-ray imaging systems. For use in generating fluoroscopic images of human anatomy.
Terminated
MQBK050489
K052412 +2
Mar 1, 2013Philips Healthcare Inc.
Philips Digital Diagnost Stationary radiographic system
Terminated
MQBK982795
Feb 26, 2013Philips Healthcare Inc.
Philips DigitalDiagnost X-Ray System with Eleva Software 2.1.3 Model numbers 712020, 712022, and 712082 Product Usage: Digital radiographic system
Terminated
MQBK982795
Dec 5, 2012Philips Healthcare Inc.
Philips Digital Diagnost Software Version R2.0.2 Product Usage: This system is used for making X-ray exposures for diagnostics
Terminated
MQBK982795
Sep 28, 2012Philips Healthcare Inc.
Philips Digital Diagnost with patient carriage Model: 712050 with serial number range from 00 000 00 to 09 000 543. Product Usage: Stationary radiographic System
Terminated
MQBK982795
Sep 28, 2012Eos Imaging Inc
EOS X-ray Medical Diagnostic , X-ray Equipment System Digital Radiography used in general radiographic examination.
Terminated
MQBNone listed
Sep 27, 2012Philips Healthcare Inc.
Philips Digital Diagnost-Mobile Detector Holder for Digital Diagnost (Single Detector, Dual Detector, Release 3) System codes: 712020, 712022, 712025 This system is used for making X-ray exposures fo
Terminated
MQBK982795
Sep 14, 2012Philips Healthcare Inc.
Philips DigitalDiagnost Systems with M Cabinet Model: 712025 Stationary radiographic system, digital-Universal RAD Applications
Terminated
MQBK982795
Sep 13, 2012GE Healthcare, LLC
GE Healthcare, Innova 2121IQ, Innova 3131IQ Cardiovascular X-ray imaging systems. K060259: The Innova 3131IQ (3131-IQ) and 2121 IQ (2121-IQ) biplane systems are indicated for use in generating fluoros
Terminated
MQBK060259
K061163 +1
Aug 24, 2012Canon Inc.
Canon Solid State X-ray Imager (Flat Panel/Digital Imager), Digital Radiography, Models CXDI-55C, CXDI-55G and CXDI-70C. These devices are intended to replace radiographic film/screen systems in all g
Terminated
MQBK091435
K091436 +1
Aug 13, 2012Carestream Health, Inc.
Carestream DRX-1 System Battery --- Made in U.S.A. for Carestream Health, Inc., Carestream Health, Inc., 150 Verona St, Rochester, NY 14608. --- The battery may be sold with the DRX-1 imaging device o
Terminated
MQBK090318
Jun 15, 2012Philips Healthcare Inc.
Philips Digital Diagnost Software, software release 2.0.2 and 2.0.2SP1 including mirror icon Stationary Fluoroscopic system
Terminated
MQBK982795
Jun 8, 2012General Electric Med Systems LLC
GE Healthcare Definium 8000 Digital Radiographic Systems : GE Healthcare, 3000 North Grandview , Waukesha, WI, 53188 Model Number: 5131070. The Revolution XR/d with Tomosynthesis is intended for use
Terminated
MQBK012389
Jun 8, 2012General Electric Med Systems LLC
GE Healthcare Revolution XR/d; GE Healthcare, 3000 North Grandview , Waukesha, WI, 53188 Model numbers: 2259988-2 & 2351505. The Revolution XR/d Digital Radiographic Imaging System is indicated for u
Terminated
MQBK051967
Apr 26, 2012Philips Healthcare Inc.
Philips Digital Diagnost Systems with Eleva software version 2.x and stitching option Intended use: Stationary radiographic system, Radiographic system, digital
Terminated
MQBK982795
Apr 9, 2012Siemens Medical Solutions USA, Inc
Siemens Axiom Luminos dRF solid state x-ray imager Solid state x-ray imager (flat panel/dig. imager)
Terminated
MQBK062623
Mar 5, 2012Siemens Medical Solutions USA, Inc
Siemens Ysio, AXIOM Luminos dRF, AXIOM Luminos Agile/TF, Uroskop Omnia Solid state x-ray imager (flat panel/digital imager)
Terminated
MQBK062623
K081722 +2
Feb 19, 2012AGFA Corp.
Agfa DX-D Imaging Package - (The detector power cables described in the Report of Correction and Removal are connected to portable detector panels used in the DX-D systems) Product Usage: DX-D Imagin
Terminated
MQBK092669
Feb 2, 2012Toshiba American Medical Systems Inc
DRAD-3000E: Radrex-i X-ray is a general purpose X-ray System. Labeling reads in part "TOSHIBA***DIGITAL RADIOGRAPHY SYSTEM RADREX-i DRAD-3000E Systems Data No. MSDXR0144EA***"
Terminated
MQBK083503
Jan 25, 2012Siemens Medical Solutions USA, Inc
Siemens AXIOM Aristos FX Plus solid state x-ray imager. Image-intensified fluoroscopic x-ray system.
Terminated
MQBK061054
Jan 11, 2012AGFA Corp.
Agfa Computed Radiography Systems with DX-G Digitizer. DX-G Digitizers haved the same intended use as the predicate devices. they are intended to use in providing diagnostic images to aid the physici
Terminated
MQBK092238
Dec 1, 2011Toshiba American Medical Systems Inc
Model CAT-850B Catheterization Table, a component of the Toshiba INFX-8000 series X-Ray Interventional System. These systems are single or dual plane systems that employ x-rays to obtain fluoroscopy
Terminated
MQBK081582
K081621 +2
Nov 30, 2011Philips Healthcare Inc.
Philips Digital Diagnost Rel 3, a radiographic system, digital Intended use: Radiographic system, digital
Terminated
MQBK982795
Oct 28, 2011GE Healthcare, LLC
GE Healthcare, Innova 3100IQ (Optima Edition) Fluoroscopic Vascular X-ray System. Indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interve
Terminated
MQBK042053
K052157 +3
Jul 11, 2011Siemens Medical Solutions USA, Inc
Siemens YSIO - solid state x-ray imager Solid state x-ray imager (flat panel/digital imager), image-intensified fluoroscopic x-ray system
Terminated
MQBK081722
May 4, 2011AGFA Corp.
NX is the radiographer's image identification and quality control tool. It offers a broad array of features developed especially to meet the needs of the radiographer. Standard tasks are completed qui
Terminated
MQBK071162
Feb 23, 2011Siemens Medical Solutions USA, Inc
AXIOM SIRESKOP SD, SIRESKOP SX, AXIOM LUMINOS System, X-Ray, Fluoroscopic, image-intensified; solid state x-ray imager (flat panel/digital imager)
Terminated
MQBK051602
K062623 +1
Dec 17, 2010Siemens Medical Solutions USA, Inc
Axiom Luminos dRF Intended use: solid state x-ray imager (flat panel/digital imager)
Terminated
MQBK062623

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