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) |
|---|---|---|---|
| Nov 26, 2010 | AGFA Corp. DX-G Digitizer, manufactured by Agfa-Gevart NV, Mortsel, Belgium. Terminated |
MQB | K092238 |
| Nov 17, 2010 | GE Healthcare, LLC Innova 4100/4100IQ 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 | K052157 K052412 +1 |
| Nov 17, 2010 | GE Healthcare, LLC Innova 3100/3100IQ 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 s Terminated |
MQB | K052157 K052412 +1 |
| Nov 17, 2010 | GE Healthcare, LLC 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)
The Innova systems are indicated for Terminated |
MQB | K050489 K052157 +2 |
| Nov 17, 2010 | GE Healthcare, LLC Innova 2121-IQ/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 ana Terminated |
MQB | K061163 |
| Nov 16, 2010 | GE Healthcare, LLC Innova 2000 The principle system components include a C-arm, image acquisition, processing and archiving capabilities.
The Innova systems are indicated for use in generating fluoroscopic images of hum Terminated |
MQB | K024200 K993037 |
| Nov 16, 2010 | GE Healthcare, LLC Innova 4100/4100IQ 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 | K023178 K993037 |
| Aug 19, 2010 | GE Healthcare, LLC Innova 2000, manufactured by GE Medical Systems, SCS Terminated |
MQB | K022322 K024200 +1 |
| Aug 13, 2010 | Siemens Medical Solutions USA, Inc SIEMENS AXIOM Luminos TF and Sireskop SD Solid State x-ray imager (flat panel/digital imager), Fluoroscopic x-ray diagnostic system. Terminated |
MQB | K051602 K062623 |
| Jul 26, 2010 | AGFA Corp. 19" Barco MFCD 1219 (Touch Screen) + Low Profile Stand and Rack with LCD Arm
Agfa's Computed Radiography Systems with NX2.X software are indicated for use in providing diagnostic quality images to ai Terminated |
MQB | K071162 |
| Jun 29, 2010 | Ge Healthcare, Llc Innova 4100/4100IQ system with InnovaIQ Table Option
Indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and opti Terminated |
MQB | K023178 K031637 +3 |
| Jun 29, 2010 | Ge Healthcare, Llc Innova 3100/ 3100IQ system with InnovaIQ Table Option
Indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and opti Terminated |
MQB | K023178 K031637 +3 |
| Jun 29, 2010 | Ge Healthcare, Llc Innova 2100IQ system with InnovaIQ Table Option
Indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally Terminated |
MQB | K023178 K031637 +3 |
| May 28, 2010 | Siemens Medical Solutions USA, Inc Axiom Artis systems with Motor Controller Unit. Siemens Medical Solutions USA, Inc. Malvern, PA 19355.
Intended for x-ray, angiographic use. Terminated |
MQB | K021021 |
| May 26, 2010 | Ge Healthcare, Llc 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) Terminated |
MQB | K050489 K052157 +2 |
| May 26, 2010 | Ge Healthcare, Llc GE Healthcare, Innova 3100 IQ : GE Innova 3100 / 3100 IQ, Cardiovascular Imaging System, (The system consists of an a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital d Terminated |
MQB | K052157 K052412 +1 |
| May 26, 2010 | Ge Healthcare, Llc GE Healthcare, Innova 4100 IQ: GE Innova 4100 / 4100 IQ., Cardiovascular Imaging System (The system consists of an a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital de Terminated |
MQB | K052157 K052412 +1 |
| Apr 5, 2010 | Siemens Medical Solutions USA, Inc Axiom Artis Systems operating with A100 Generator Terminated |
MQB | K021021 |
| Mar 23, 2010 | Philips Medical Systems North America Co. Phillips DigitalDiagnost. General radiographic examinations and applications wherever a solid state X-ray imaging device can be used. Terminated |
MQB | K982795 |
| Mar 22, 2010 | Toshiba American Medical Systems Inc Toshiba America Medical Systems Inc (TAMS) Digital Radiography System Radrex-i DRAD-3000E; Electrostatic x-ray imaging system Terminated |
MQB | K073165 |
| Jan 13, 2010 | GE Medical Systems, LLC Omega IV and Omega V tables on GE Innova 2121-1Q/3131--1Q Biplane Cardiovascular Imaging System. Terminated |
MQB | K061163 |
| Jan 13, 2010 | GE Medical Systems, LLC Omega IV and Omega V tables on GE Innova 2000 fluoroscopic x-ray system Terminated |
MQB | K022322 K024200 +1 |
| Jan 13, 2010 | GE Medical Systems, LLC Omega IV and Omega V tables on GE Innova 4100/4100IQ GE Innova 4100 / 4100 IQ., x-ray system Terminated |
MQB | K023178 K052157 +2 |
| Jan 13, 2010 | GE Medical Systems, LLC Omega IV and Omega V tables on GE Innova 3100/3100IQ GE Innova 3100 / 3100 IQ, Cardiovascular Imaging System Terminated |
MQB | K031637 K052157 +2 |
| Jan 13, 2010 | GE Medical Systems, LLC Omega IV and Omega V tables on GE Innova 2100IQ Digital Fluoroscopic Imaging System Terminated |
MQB | K050489 K052157 +2 |
| Jan 13, 2010 | GE Medical Systems, LLC Omega IV and Omega V tables on GE Advantx-E imaging system, used for general purpose diagnostic angiographic fluoroscopy and radiographic studies. Terminated |
MQB | K945375 K960575 +1 |
| Dec 16, 2009 | GE Medical Systems, LLC GE Healthcare, Innova 2121-1Q/3131-1Q Biplane Cardiovascular Imaging Systems.
Indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventi Terminated |
MQB | K060259 |
| Nov 9, 2009 | GE Medical Systems, LLC GE Healthcare, GE Innova 3100 / 3100 IQ, 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 K042053 +3 |
| Sep 28, 2009 | Toshiba American Medical Systems Inc Toshiba Infinix fluoroscopy DFP-8000D Digital Radiography System with version 3.40 or higher software. Controller for Infinix interventional angiography systems. Terminated |
MQB | K081624 |
| Sep 24, 2009 | Ge Healthcare GE Innova 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 ge Terminated |
MQB | K023178 K052412 +1 |
| Sep 24, 2009 | Ge Healthcare GE Innova 4100, 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 gener Terminated |
MQB | K023178 K052412 +1 |
| Sep 24, 2009 | Ge Healthcare GE Innova 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 detect Terminated |
MQB | K031637 K052412 +1 |
| Sep 24, 2009 | Ge Healthcare GE Innova 3100, 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 detector) Terminated |
MQB | K031637 K052412 +1 |
| Sep 24, 2009 | 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 K061163 |
| Sep 24, 2009 | GE Medical Systems, LLC 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 in Terminated |
MQB | K052412 |
| Sep 24, 2009 | GE Medical Systems, LLC Innova 4100/4100IQ 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 |
| Sep 24, 2009 | GE Medical Systems, LLC Innova 3100/3100IQ 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 s Terminated |
MQB | K031637 K042053 |
| Sep 24, 2009 | GE Medical Systems, LLC GE, Innova 2000 The principle system components include a C-arm, image acquisition, processing and archiving capabilities.
Innova 2000 The principle system components include a C-arm, image acquisiti Terminated |
MQB | K024200 |
| Jun 19, 2009 | GE Medical Systems, LLC GE Innova 4100 / 4100 IQ Cardiovascular Imaging System, GE Healthcare, Waukesha, WI 53188.
The product is indicated for use in generating fluoroscopic images of human anatomy for vascular angiography Terminated |
MQB | K023178 K042053 +3 |
| Jun 19, 2009 | GE Medical Systems, LLC GE Innova 3100 / 3100 IQ Cardiovascular Imaging System, GE Healthcare, Waukesha, WI 53188.
The product is indicated for use in generating fluoroscopic images of human anatomy for vascular angiography Terminated |
MQB | K031637 K042053 +3 |
| Jun 19, 2009 | GE Medical Systems, LLC GE Innova 2100 IQ Versatile Cardiac and Vascular Imaging System, GE Healthcare, Waukesha, WI 53188.
The product is indicated for use in generating fluoroscopic images of human anatomy for vascular an Terminated |
MQB | K050489 K052157 +2 |
| May 19, 2009 | GE Medical Systems, LLC Innova 2121-IQ/3131-IQ 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 | K060259 K061163 |
| May 6, 2009 | Siemens Medical Solutions USA, Inc AXIOM Sireskop SD Model numbers 8890415 and 8890407. The product is intended for use as radiographic and fluoroscopic imaging device. Terminated |
MQB | K051602 |
| Mar 12, 2009 | GE Medical Systems, LLC 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 |
| Mar 12, 2009 | GE Medical Systems, LLC 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 |
| Jan 21, 2009 | GE Medical Systems, LLC 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 i Terminated |
MQB | K023178 K042053 +3 |
| Jan 21, 2009 | GE Medical Systems, LLC 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 +3 |
| Jan 21, 2009 | GE Medical Systems, LLC 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 | K050489 K052157 +2 |
| Nov 28, 2008 | Siemens Medical Solutions USA, Inc Axiom Luminos dRF without ST filter. . Solid state x-ray imager (flat panel/digital imager). Model number 10252048.
Universal fluoroscopic x-ray diagnostic system. Terminated |
MQB | K062623 |
| Nov 28, 2008 | Siemens Medical Solutions USA, Inc Axiom Luminos dRF with ST filter. Solid state x-ray imager (flat panel/digital imager). Model number 10252047.
Universal fluoroscopic x-ray diagnostic system. Terminated |
MQB | K062623 |
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