ClearanceBrief
Company ยท US

Fischer Imaging Corp.

FDA 510(k) clearances and medical device recalls filed under this name, 1981 to 2004. Name variants (Inc, Corp, punctuation) are merged.

69510(k) clearances (0 in 12 months)
11recalls (0 in 12 months)
7recalls that name a 510(k)

Product codes

CodeDeviceRecords
IZOGenerator, High-Voltage, X-Ray, Diagnostic22
JAASystem, X-Ray, Fluoroscopic, Image-Intensified14
IZHSystem, X-Ray, Mammographic9
IXRTable, Radiographic, Tilting8
IYBTube Mount, X-Ray, Diagnostic7
IZISystem, X-Ray, Angiographic4
MUEFull Field Digital, System, X-Ray, Mammographic2
OXOImage-Intensified Fluoroscopic X-Ray System, Mobile2
EHDUnit, X-Ray, Extraoral With Timer1
ITYAssembly, Tube Housing, X-Ray, Diagnostic1
IXLDevice, Spot-Film1
IYOSystem, Imaging, Pulsed Echo, Ultrasonic1
IZZTable, Radiographic, Non-Tilting, Powered1
JACSystem, X-Ray, Film Marking, Radiographic1
JOQGenerator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only)1
KPQSystem, Simulation, Radiation Therapy1
KXHCradle, Patient, Radiologic1
LMCCamera, Multi Format, Radiological1
MWPCabinet, X-Ray System1
OWBInterventional Fluoroscopic X-Ray System1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Oct 29, 2004K042095MAMMOTEST
Fischer Imaging Corp.
IZH
Jun 13, 2002K021113MAMMOPATH
Fischer Imaging Corp.
MWP
Jul 16, 1998K981414LC POSITIONER
Fischer Imaging Corp.
JAA
Nov 10, 1997K973400MAMMOTEST ADAPTER DRIVER
Fischer Imaging Corp.
IZH
Mar 4, 1997K964806MD-1835
Fischer Imaging Corp.
IXL
Aug 20, 1996K961207EP-X BIPLANE
Fischer Imaging Corp.
JAA
May 3, 1996K961022TANGENT VI TABLE
Fischer Imaging Corp.
IXR
Mar 23, 1995K950291DIGITAL 625HF
Fischer Imaging Corp.
IZO
Mar 23, 1995K945619ATHENA HFX
Fischer Imaging Corp.
IZH
Sep 16, 1994K944150MICRO X-65 HF
Fischer Imaging Corp.
IZO
Sep 16, 1994K944149MICRO X-80 HF
Fischer Imaging Corp.
IZO
Sep 16, 1994K944148MICRO X-30HF
Fischer Imaging Corp.
IZO
Sep 16, 1994K944147MICRO X-50 HF
Fischer Imaging Corp.
IZO
Aug 17, 1994K943504RSX-525HF
Fischer Imaging Corp.
IZO
May 9, 1994K926560EPIC (ELECTROPHYSIOLOGY IMAGING COMPUTER
Fischer Imaging Corp.
JAA
Nov 3, 1993K934481EP-X
Fischer Imaging Corp.
JAA
May 19, 1993K930792RSX 30HF
Fischer Imaging Corp.
IZO
Mar 30, 1993K926575MAMMOTEST PRODUCT, MODIFICATION
Fischer Imaging Corp.
EHD
Dec 28, 1992K924137CSP-A (CEILING SUSPENDED POSITIONER-ANGIO)
Fischer Imaging Corp.
IZI
Nov 27, 1992K924345RADIOGRAPHIC FILM MARKETING SYSTEM
Fischer Imaging Corp.
JAC
Oct 15, 1992K914748COMET C-125
Fischer Imaging Corp.
OXO
Sep 11, 1992K922454MOBILE ATHENA HF
Fischer Imaging Corp.
IZH
Sep 10, 1992K923061MAMMOSCAN
Fischer Imaging Corp.
IZH
Jan 24, 1992K915853TANGENT V
Fischer Imaging Corp.
IXR
Jan 23, 1992K915199STORZ IMAGING SYSTEM
Fischer Imaging Corp.
IZI
Jan 13, 1992K915592PEGASUS LATERAL CARDIAC POSITIONER
Fischer Imaging Corp.
JAA
Nov 27, 1991K914266MICRO-X 30 HF
Fischer Imaging Corp.
IZO
Nov 27, 1991K914236MICRO-X 50 HF
Fischer Imaging Corp.
IZO
Nov 27, 1991K905694FVP-1000 FAMILY AND FVP-1000D FAMILY
Fischer Imaging Corp.
JAA
Oct 4, 1991K912741ELITE R 90/15
Fischer Imaging Corp.
IXR
Sep 19, 1991K910647XIMATRON/CT OPTION
Fischer Imaging Corp.
KPQ
Aug 28, 1991K912449MICRO-X 15 HF
Fischer Imaging Corp.
IZO
Aug 28, 1991K912448CSP
Fischer Imaging Corp.
OWB
Aug 2, 1991K912586TANGENT IV
Fischer Imaging Corp.
IXR
Mar 6, 1991K905695MICRO-X 80HF
Fischer Imaging Corp.
IZO
Jan 18, 1991K905501ELITE 5000
Fischer Imaging Corp.
IXR
Mar 28, 1990K900989ATHENA-HF MAMMOGRAPHIC X-RAY SYSTEM
Fischer Imaging Corp.
IZH
Feb 26, 1990K900234PFM-90 CEILING TUBE SUPPORT
Fischer Imaging Corp.
IYB
Sep 18, 1989K894913DA-100HS
Fischer Imaging Corp.
JAA
Jul 20, 1989K893674RME 325R
Fischer Imaging Corp.
IZO
Jul 20, 1989K893673RMS 180
Fischer Imaging Corp.
IXR
Jun 23, 1989K893653RADIOGRAPHIC CEILING TUBE SUPPORT CTS15
Fischer Imaging Corp.
IYB
Jun 23, 1989K893652RADIOGRAPHIC FLOOR MOUNTED TUBESTAND FM 60
Fischer Imaging Corp.
IYB
Mar 31, 1989K884292STRETCHER TABLE
Fischer Imaging Corp.
KXH
Feb 16, 1989K885127SIS 2000 MAMMOGRAPHIC X-RAY SYSTEM
Fischer Imaging Corp.
LMC
Dec 13, 1988K883976CFX 625
Fischer Imaging Corp.
IZO
Nov 21, 1988K883985CARDIAC CX
Fischer Imaging Corp.
JAA
Nov 21, 1988K883860ADVANTAGE
Fischer Imaging Corp.
IZI
Nov 21, 1988K883831IMAGER
Fischer Imaging Corp.
IZI
Oct 21, 1988K884134MICRO-X 100CP
Fischer Imaging Corp.
IZO

Newest 50 of 69.

Latest recalls

DateFirm and productCodeLinked 510(k)
Apr 11, 2006Fischer Imaging Corporation
SenoScan Full Field Digital Mammography System--Product Number 94001G-3, 105200G
Terminated		 MUENone listed
Sep 9, 2005Fischer Imaging Corporation
Electrophysiology Imaging System
Terminated		 JAANone listed
Sep 9, 2005Fischer Imaging Corporation
Electrophysiology Imaging System
Terminated		 JAAK912448
K934481 +1
Sep 9, 2005Fischer Imaging Corporation
Electrophysiology Imaging System
Terminated		 JAAK912448
K934481 +1
Sep 9, 2005Fischer Imaging Corporation
Electrophysiology Imaging System
Terminated		 JAAK912448
K934481 +1
May 3, 2005Fischer Imaging Corporation
VersaRad Generator
Terminated		 IYBK880530
Apr 19, 2005Fischer Imaging Corporation
Bloom DTU-215-B Programmable Stimulator
Terminated		 JOQK991293
Jan 5, 2005Fischer Imaging Corporation
MammoTest Breast Biopsy System.
Terminated		 IZHK861692
Jul 20, 2004Fischer Imaging Corporation
Fischer SenoScan True View Digital Mammography System.
Terminated		 MUENone listed
Jul 20, 2004Fischer Imaging Corporation
VersaRad/Traumex General Radiographic System.
Terminated		 IYBK880530
Jul 20, 2004Fischer Imaging Corporation
SenoScan True View Digital Mammography System
Terminated		 ITYNone listed
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