ClearanceBrief
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)
Nov 26, 2010AGFA Corp.
DX-G Digitizer, manufactured by Agfa-Gevart NV, Mortsel, Belgium.
Terminated
MQBK092238
Nov 17, 2010GE 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
MQBK052157
K052412 +1
Nov 17, 2010GE 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
MQBK052157
K052412 +1
Nov 17, 2010GE 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
MQBK050489
K052157 +2
Nov 17, 2010GE 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
MQBK061163
Nov 16, 2010GE 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
MQBK024200
K993037
Nov 16, 2010GE 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
MQBK023178
K993037
Aug 19, 2010GE Healthcare, LLC
Innova 2000, manufactured by GE Medical Systems, SCS
Terminated
MQBK022322
K024200 +1
Aug 13, 2010Siemens 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
MQBK051602
K062623
Jul 26, 2010AGFA 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
MQBK071162
Jun 29, 2010Ge 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
MQBK023178
K031637 +3
Jun 29, 2010Ge 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
MQBK023178
K031637 +3
Jun 29, 2010Ge 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
MQBK023178
K031637 +3
May 28, 2010Siemens 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
MQBK021021
May 26, 2010Ge 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
MQBK050489
K052157 +2
May 26, 2010Ge 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
MQBK052157
K052412 +1
May 26, 2010Ge 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
MQBK052157
K052412 +1
Apr 5, 2010Siemens Medical Solutions USA, Inc
Axiom Artis Systems operating with A100 Generator
Terminated
MQBK021021
Mar 23, 2010Philips Medical Systems North America Co. Phillips
DigitalDiagnost. General radiographic examinations and applications wherever a solid state X-ray imaging device can be used.
Terminated
MQBK982795
Mar 22, 2010Toshiba American Medical Systems Inc
Toshiba America Medical Systems Inc (TAMS) Digital Radiography System Radrex-i DRAD-3000E; Electrostatic x-ray imaging system
Terminated
MQBK073165
Jan 13, 2010GE Medical Systems, LLC
Omega IV and Omega V tables on GE Innova 2121-1Q/3131--1Q Biplane Cardiovascular Imaging System.
Terminated
MQBK061163
Jan 13, 2010GE Medical Systems, LLC
Omega IV and Omega V tables on GE Innova 2000 fluoroscopic x-ray system
Terminated
MQBK022322
K024200 +1
Jan 13, 2010GE Medical Systems, LLC
Omega IV and Omega V tables on GE Innova 4100/4100IQ GE Innova 4100 / 4100 IQ., x-ray system
Terminated
MQBK023178
K052157 +2
Jan 13, 2010GE Medical Systems, LLC
Omega IV and Omega V tables on GE Innova 3100/3100IQ GE Innova 3100 / 3100 IQ, Cardiovascular Imaging System
Terminated
MQBK031637
K052157 +2
Jan 13, 2010GE Medical Systems, LLC
Omega IV and Omega V tables on GE Innova 2100IQ Digital Fluoroscopic Imaging System
Terminated
MQBK050489
K052157 +2
Jan 13, 2010GE 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
MQBK945375
K960575 +1
Dec 16, 2009GE 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
MQBK060259
Nov 9, 2009GE 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
MQBK031637
K042053 +3
Sep 28, 2009Toshiba 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
MQBK081624
Sep 24, 2009Ge 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
MQBK023178
K052412 +1
Sep 24, 2009Ge 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
MQBK023178
K052412 +1
Sep 24, 2009Ge 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
MQBK031637
K052412 +1
Sep 24, 2009Ge 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
MQBK031637
K052412 +1
Sep 24, 2009Ge 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
MQBK052412
K061163
Sep 24, 2009GE 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
MQBK052412
Sep 24, 2009GE 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
MQBK042053
Sep 24, 2009GE 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
MQBK031637
K042053
Sep 24, 2009GE 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
MQBK024200
Jun 19, 2009GE 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
MQBK023178
K042053 +3
Jun 19, 2009GE 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
MQBK031637
K042053 +3
Jun 19, 2009GE 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
MQBK050489
K052157 +2
May 19, 2009GE 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
MQBK060259
K061163
May 6, 2009Siemens 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
MQBK051602
Mar 12, 2009GE 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
MQBK023178
K042053
Mar 12, 2009GE 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
MQBK031637
K042053
Jan 21, 2009GE 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
MQBK023178
K042053 +3
Jan 21, 2009GE 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
MQBK031637
K042053 +3
Jan 21, 2009GE 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
MQBK050489
K052157 +2
Nov 28, 2008Siemens 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
MQBK062623
Nov 28, 2008Siemens 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
MQBK062623

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