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) |
|---|---|---|---|
| Oct 10, 2008 | Siemens Medical Solutions USA, Inc AXIOM Luminos TF, model number 10093902
Intended to be used for procedures that involve high skin doses, which can result in deterministic effects. Terminated |
MQB | K051602 |
| Sep 30, 2008 | Datex - Ohmeda, Inc GE Healthcare Innova 4100 Digital Fluoroscopic Imaging (Cardiovascular Imaging System Terminated |
MQB | K023178 K031637 |
| Sep 30, 2008 | Datex - Ohmeda, Inc GE Healthcare Innova 3100 Digital Fluoroscopic Imaging (Cardiovascular Imaging System) Terminated |
MQB | K031637 K042053 |
| Sep 30, 2008 | Datex - Ohmeda, Inc GE Healthcare Innova 4100 IQ Digital Fluoroscopic Imaging System (Vascular Angiography system). The Innova systems are indicated for use in generating fluoroscopic images of human anatomy for vascul Terminated |
MQB | K050489 K052157 +1 |
| Sep 30, 2008 | Datex - Ohmeda, Inc GE Healthcare Innova 3100 IQ Digital Fluoroscopic Imaging System (Cardiovascular imaging system). The Innova systems are indicated for use in generating fluoroscopic images of human anatomy for vascu Terminated |
MQB | K050489 K052157 +1 |
| Sep 30, 2008 | Datex - Ohmeda, Inc GE Healthcare Innova 2100 IQ Digital Fluoroscopic Imaging System (Versatile cardiac and Vascular imaging system). The Innova systems are indicated for use in generating fluoroscopic images of human a Terminated |
MQB | K050489 K052157 +1 |
| Sep 29, 2008 | GE Healthcare GE Healthcare Innova 4100 Digital Fluoroscopic Imaging System with Bolus Chasing option. Terminated |
MQB | K042053 |
| Sep 29, 2008 | GE Healthcare GE Healthcare Innova 3100 Digital Fluoroscopic Imaging System with Bolus Chasing option. Terminated |
MQB | K042053 |
| Sep 21, 2008 | GE Healthcare Innova 2000 The principle system components include a C-arm, image acquisition, processing and archiving capabilities. The product is indicated for use in generating fluoroscopic images of human ana Terminated |
MQB | K050489 |
| Sep 21, 2008 | GE Healthcare Innova 2121-1Q/3131-1Q Biplane Cardiovascular Imaging System. The Innova Biplane systems are the first and only digital flat panel biplane systems with a full sized lateral plane to cover lateral anat Terminated |
MQB | K061163 |
| Sep 21, 2008 | GE Healthcare Advantx-E The Advantx imaging system is intended to be used for general purpose diagnostic angiographic fluoroscopy and radiographic studies. Terminated |
MQB | K945375 K960575 +1 |
| Sep 21, 2008 | GE Healthcare GE Innova 4100 / 4100 IQ. , GE Healthcare, Waukesha, WI 53188 ( The system consists of an a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector) The product is Terminated |
MQB | K023178 K042053 +1 |
| Sep 21, 2008 | GE Healthcare GE Innova 2100IQ Versatile Cardiac and Vascular Imaging System, GE Healthcare, Waukesha, WI 53188 ( The system consists of an a monoplane positioner, a vascular or cardiac table, an X-ray system and a Terminated |
MQB | K052412 |
| Sep 21, 2008 | GE Healthcare GE Innova 3100 / 3100 IQ, Cardiovascular Imaging System, GE Healthcare, Waukesha, WI 53188 (The system consists of an a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital Terminated |
MQB | K031637 K042053 +1 |
| Sep 20, 2008 | GE Healthcare Innova 4100 / 4100 IQ , GE Healthcare, Waukesha, WI 53188 (The system consists of an a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector)
Indicated for use in Terminated |
MQB | K023178 K042053 +3 |
| Sep 20, 2008 | GE Healthcare Innova 3100 / 3100 IQ, Cardiovascular Imaging System, GE Healthcare, Waukesha, WI 53188 (The system consists of an a monoplane
Indicated for use in generating fluoroscopic images of human anatomy fo Terminated |
MQB | K031637 K042053 +2 |
| Sep 20, 2008 | GE Healthcare Innova 2100IQ (The Digital Fluoroscopic Imaging System consists of an a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector)
Indicated for use in generating flu Terminated |
MQB | K050489 K052157 +1 |
| Sep 20, 2008 | GE Healthcare Innova 2000; The principle system components include a C-arm, image acquisition, processing and archiving capabilities.
Indicated for use in generating fluoroscopic images of human anatomy for vascul Terminated |
MQB | K022322 K024200 +1 |
| Sep 16, 2008 | GE Healthcare Innova 2121-1Q/3131-1Q is a Biplane Cardiovascular Imaging System.
The Innova Biplane systems are the first and only digital flat panel biplane system with a full sized lateral plane to cover lateral Terminated |
MQB | K061163 |
| Sep 16, 2008 | GE Healthcare Innova 2000's principle system components include a C-arm, image acquisition, processing and archiving capabilities. Terminated |
MQB | K024200 |
| Sep 16, 2008 | GE Healthcare Innova 4100/4100IQ is a X-Ray system that consists of an a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector. Terminated |
MQB | K023178 K052157 +2 |
| Sep 16, 2008 | GE Healthcare Innova 3100/3100IQ is a cardiovascular Imaging System. The system consists of an a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector. Terminated |
MQB | K031637 K052157 +2 |
| Sep 16, 2008 | GE Healthcare Innova 2100IQ is a Digital Fluoroscopic Imaging System that consists of an a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector. Terminated |
MQB | K050489 K052157 +2 |
| Jan 31, 2008 | GE Healthcare GE Innova 4100 / 4100 IQ. , GE Healthcare, Waukesha, WI 53188 ( The system consists of an a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector) Terminated |
MQB | K042053 K052157 +1 |
| Jan 31, 2008 | GE Healthcare GE Innova 3100 / 3100 IQ, Cardiovascular Imaging System, GE Healthcare, Waukesha, WI 53188 (The system consists of an a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital Terminated |
MQB | K042053 K052157 +1 |
| Jan 31, 2008 | GE Healthcare GE Innova 2100IQ Versatile Cardiac and Vascular Imaging System, GE Healthcare, Waukesha, WI 53188 ( The system consists of an a monoplane positioner, a vascular or cardiac table, an X-ray system and Terminated |
MQB | K050489 |
| Nov 27, 2007 | Toshiba American Med Sys Inc Toshiba-Interventional Angiography System, Infinix i, Model DFP-8000D, equiped with Digital Radiography System with Software version 3.4er000, Toshiba America Medical Systems, Inc., Tustine, CA 92780 Terminated |
MQB | K052884 |
| Sep 28, 2007 | GE Healthcare GE Innova 2100-IQ Digital Fluoroscopic Imaging System, Versatile cardiac and vascular imaging system. GE Healthcare Americas P.O.Box 414, Milwaukee, Wisconsin 53201, U.S.A. Terminated |
MQB | K050489 |
| Sep 25, 2007 | Philips Medical Systems North America Co. Phillips Philips Digital Diagnost X-Ray system Terminated |
MQB | K982795 |
| Jul 10, 2007 | General Electric Med Systems LLC GE Healthcare Innova 3100/ 3100 IQ Digital Fluoroscopic Imaging System (Cardiovascular Imaging System) Terminated |
MQB | K023178 K031637 +4 |
| Jul 10, 2007 | General Electric Med Systems LLC GE Healthcare Innova 2100 IQ Digital Fluoroscopic Imaging System (Versatile cardiac and vascular). Terminated |
MQB | K023178 K031637 +4 |
| Jun 9, 2007 | General Electric Med Systems LLC GE Healthcare Innova 4100/ 4100 IQ Digital Fluoroscopic Imaging System (Vascular Angiography System). Terminated |
MQB | K023178 |
| Jun 9, 2007 | General Electric Med Systems LLC GE Healthcare Innova 3100/3100 IQ Digital Fluoroscopic Imaging system ( Cardiovascular Imaging System). Terminated |
MQB | K031637 |
| Jun 9, 2007 | General Electric Med Systems LLC GE Healthcare Innova 2100 IQ Digital Fluoroscopic Imaging System (Versatile cardiac and vascular imaging system.). Terminated |
MQB | K052412 |
| Jun 5, 2007 | General Electric Med Systems LLC GE Healthcare Innova 2100 IQ Digital Fluoroscopic Imaging System (Versatile cardiac and vascular) Terminated |
MQB | K023178 K031637 +4 |
| Jun 5, 2007 | General Electric Med Systems LLC GE Healthcare Innova 3100/ 3100 IQ Digital Fluoroscopic Imaging System (Cardiovascular Imaging System) Terminated |
MQB | K023178 K031637 +4 |
| Jun 5, 2007 | General Electric Med Systems LLC GE Healthcare Innova 4100/4100 IQ. Digital Fluoroscopic Imaging System (Vascular Angiography System) Terminated |
MQB | K023178 K031637 +4 |
| Oct 12, 2006 | AGFA Corp. CR DX-S, Image Intensified Fluoroscopic X-ray system. Terminated |
MQB | K050810 |
| Aug 31, 2006 | Konica Minolta Medical Imaging USA, Inc. Regius Model 370 Digital Radiography
Konica Minolta Terminated |
MQB | K051418 |
| May 24, 2006 | GE Healthcare GE Healthcare Innova 4100 and Innova 4100 with Bolus Chasing offered as an option. Digital Fluoroscopic Imaging System. Terminated |
MQB | K023178 |
| May 24, 2006 | GE Healthcare GE Healthcare Innova 3100 and Innova 3100 with Bolus Chasing offered as an option, Cardiovascular Imaging System. Terminated |
MQB | K031637 |
| May 24, 2006 | GE Healthcare GE Medical Systems Innova 2000 and Innova 2000S, and Innova 2000 and Innova 2000S mobile version. Cardiovascular Imaging System. Terminated |
MQB | K022322 K024200 |
| May 9, 2006 | AGFA Corp. CR DX-S, DX-S, Computed radiography system (Digitizer) Terminated |
MQB | K050810 |
| Oct 28, 2004 | Fujifilm Medical System USA, Inc. Genital Protector Shield used with Fuji Computed Radiography (FCR) system models 5501D and XU/D1.
Model: GP344 Terminated |
MQB | K993861 |
| Jul 20, 2004 | Fujifilm Medical System USA, Inc. Fuji Flash IIP and CR-IR346CL Consoles Terminated |
MQB | K013218 |
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