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
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 11, 2017 | Philips 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 |
MQB | K141736 |
| May 11, 2017 | Philips Electronics North America Corporation Philips DigitalDiagnost 3.1.x X-Ray System Terminated |
MQB | K141736 |
| Mar 23, 2017 | Toshiba 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 |
MQB | K122842 |
| Feb 27, 2017 | LIEBEL-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 |
MQB | K121838 |
| Dec 21, 2016 | AGFA Healthcare Corp. Agfa Healthcare NX 3.0.8950 Imaging Processing Software Terminated |
MQB | K090672 |
| Jun 3, 2016 | Philips Healthcare Philips Healthcare DigitalDiagnost stationary X-ray system Terminated |
MQB | K141736 |
| May 19, 2015 | Philips Medical Systems, Inc. Philips Healthcare DigitalDiagnost System X-Ray Terminated |
MQB | K141736 |
| May 5, 2015 | Eos Imaging Inc EOS, Digital radiography system used in general radiographic examinations. Terminated |
MQB | K123740 |
| Mar 23, 2015 | Philips 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 |
MQB | K141736 |
| Jun 4, 2014 | Toshiba 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 |
MQB | K120073 |
| Apr 24, 2014 | Philips 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 |
MQB | K982795 |
| Feb 24, 2014 | GE 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 |
MQB | K102615 |
| Jan 9, 2014 | EOS Imaging EOS System X- ray beam
Digital radiography system used in general radiographic examinations. Terminated |
MQB | None listed |
| Dec 27, 2013 | Philips 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 |
MQB | K070528 |
| Nov 7, 2013 | Carestream 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 |
MQB | K090318 |
| Jul 24, 2013 | Siemens 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 |
MQB | K983732 |
| Jun 17, 2013 | Philips Healthcare Inc. Philips Diagnost Stationary Radiographic System
Models:
712020, 712022, 712050, 712052, 712055, 712057, 712062
Product Usage:
Universal RAD Applications Terminated |
MQB | K982795 |
| Jun 17, 2013 | Philips Healthcare Inc. Philips Diagnost Stationary Radiographic System
Models:
712020, 712022, 712050, 712052, 712055, 712057, 712062
Product Usage:
Universal RAD Applications Terminated |
MQB | K982795 |
| Apr 3, 2013 | Cooper 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 |
MQB | K910253 |
| Mar 25, 2013 | Toshiba 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 |
MQB | K052884 K081624 +2 |
| Mar 19, 2013 | AGFA 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 |
MQB | K121948 |
| Mar 13, 2013 | GE 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 |
MQB | K023178 K031637 +4 |
| Mar 11, 2013 | GE 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 |
MQB | K050489 K052412 +2 |
| Mar 1, 2013 | Philips Healthcare Inc. Philips Digital Diagnost
Stationary radiographic system Terminated |
MQB | K982795 |
| Feb 26, 2013 | Philips 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 |
MQB | K982795 |
| Dec 5, 2012 | Philips Healthcare Inc. Philips Digital Diagnost Software Version R2.0.2
Product Usage:
This system is used for making X-ray exposures for diagnostics Terminated |
MQB | K982795 |
| Sep 28, 2012 | Philips 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 |
MQB | K982795 |
| Sep 28, 2012 | Eos Imaging Inc EOS X-ray Medical Diagnostic , X-ray Equipment System
Digital Radiography used in general radiographic examination. Terminated |
MQB | None listed |
| Sep 27, 2012 | Philips 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 |
MQB | K982795 |
| Sep 14, 2012 | Philips Healthcare Inc. Philips DigitalDiagnost Systems with M Cabinet
Model: 712025
Stationary radiographic system, digital-Universal RAD Applications Terminated |
MQB | K982795 |
| Sep 13, 2012 | GE 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 |
MQB | K060259 K061163 +1 |
| Aug 24, 2012 | Canon 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 |
MQB | K091435 K091436 +1 |
| Aug 13, 2012 | Carestream 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 |
MQB | K090318 |
| Jun 15, 2012 | Philips Healthcare Inc. Philips Digital Diagnost Software, software release 2.0.2 and 2.0.2SP1 including mirror icon
Stationary Fluoroscopic system Terminated |
MQB | K982795 |
| Jun 8, 2012 | General 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 |
MQB | K012389 |
| Jun 8, 2012 | General 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 |
MQB | K051967 |
| Apr 26, 2012 | Philips Healthcare Inc. Philips Digital Diagnost Systems with Eleva software version 2.x and stitching option
Intended use: Stationary radiographic system, Radiographic system, digital Terminated |
MQB | K982795 |
| Apr 9, 2012 | Siemens Medical Solutions USA, Inc Siemens Axiom Luminos dRF solid state x-ray imager
Solid state x-ray imager (flat panel/dig. imager) Terminated |
MQB | K062623 |
| Mar 5, 2012 | Siemens 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 |
MQB | K062623 K081722 +2 |
| Feb 19, 2012 | AGFA 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 |
MQB | K092669 |
| Feb 2, 2012 | Toshiba 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 |
MQB | K083503 |
| Jan 25, 2012 | Siemens Medical Solutions USA, Inc Siemens AXIOM Aristos FX Plus solid state x-ray imager.
Image-intensified fluoroscopic x-ray system. Terminated |
MQB | K061054 |
| Jan 11, 2012 | AGFA 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 |
MQB | K092238 |
| Dec 1, 2011 | Toshiba 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 |
MQB | K081582 K081621 +2 |
| Nov 30, 2011 | Philips Healthcare Inc. Philips Digital Diagnost Rel 3, a radiographic system, digital
Intended use: Radiographic system, digital Terminated |
MQB | K982795 |
| Oct 28, 2011 | GE 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 |
MQB | K042053 K052157 +3 |
| Jul 11, 2011 | Siemens 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 |
MQB | K081722 |
| May 4, 2011 | AGFA 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 |
MQB | K071162 |
| Feb 23, 2011 | Siemens 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 |
MQB | K051602 K062623 +1 |
| Dec 17, 2010 | Siemens Medical Solutions USA, Inc Axiom Luminos dRF
Intended use: solid state x-ray imager (flat panel/digital imager) Terminated |
MQB | K062623 |
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