ClearanceBrief
Panels › Radiology › Product code JAA · Class 2

System, X-Ray, Fluoroscopic, Image-Intensified

Regulation 892.1650

1510(k)s in 12 months (300 all time)
4recalls in 12 months (223 all time)
197recalls that name a 510(k)
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Top companies in JAA

Company510(k)sRecalls
Ge Oec Medical Systems140
Siemens Medical Solutions USA, Inc.1029
GE Healthcare133
Philips North America023
Philips Medical Systems North America Co. Phillips022
Shimadzu Medical Systems105
Fischer Imaging Corp.104
Philips Medical Systems Dmc GmbH59
Toshiba America Medical Systems, In.C130
General Electric Co.100
Decided510(k)Device and applicantCode
Mar 29, 2011K103038DUET DRF
Cmt Medical Technologies, Ltd., IL
JAA
Jun 30, 2010K101491UROSKOP OMNIA
Siemens Medical Solutions USA, Inc.
JAA
Oct 10, 2008K082830INFX-8000H, INFINIX-I
Toshiba America Medical Systems, In.C
JAA
Jun 23, 2008K081621INFX-8000C (INFINIX CC-I AND VC-I)
Toshiba America Medical Systems, In.C
JAA
Jun 19, 2008K081491SMITH & NEPHEW CDS SYSTEM
Smith & Nephew, Inc.
JAA
Jun 17, 2008K081582INFX-8000V, INFINIX-CFI AND INFINIX VFI
Toshiba America Medical Systems, In.C
JAA
Jun 11, 2008K081091PRECISION 500D R&F X-RAY SYSTEM
GE Healthcare
JAA
Jun 4, 2008K080859DRF 4343
Villa Sistemi Medicali S.P.A., IT
JAA
Apr 5, 2007K070390FLUOROPRO RF DIGITAL IMAGING SYSTEM
Virtual Imaging, Inc.
JAA
Jun 7, 2006K061028PRECISION THUNIS 800+
Ge Medical Systems, LLC
JAA
Nov 30, 2005K052610IMAGE STAR II
Lakeshore Technologies, Inc.
JAA
Jul 7, 2005K051602AXIOM SIRESKOP SD
Siemens Medical Systems, Inc.
JAA
Jul 1, 2005K051136SMITH & NEPHEW CDS SYSTEM
Smith & Nephew, Inc.
JAA
May 13, 2005K051025FLUOROSCAN INSIGHT MINI C-ARM FLUOROSCOPIC IMAGING SYSTEM
Hologic, Inc.
JAA
Apr 27, 2005K050866CENTRION 500 C-ARM SYSTEM
Osteosys Co.,Ltd
JAA
Apr 8, 2005K050692FLXIS
Philips Medical Systems North America Co.
JAA
Oct 22, 2004K042698UNFORS PATIENT SKIN DOSIMETER (PSD)
Unfors, Inc.
JAA
May 17, 2004K040870SHIMADZU IMAGE AMPLIFIER, MODEL IA-16L/HS
Shimadzu Corp.
JAA
Mar 20, 2003K024012OEC 9800 E/CV+ DIGITAL MOBILE IMAGING SYSTEM
Ge Oec Medical Systems
JAA
Dec 2, 2002K022911MODEL AMI1200 C-ARM
Integrity Practice Management, Inc.
JAA
Nov 22, 2002K022899PHILIPS INTEGRIS ALLURA FLAT DETECTOR RELEASE 1.0
Philips Medical Systems North America Co.
JAA
Oct 8, 2002K022565TELSTAR BIPLANE DIGITAL IMAGING SYSTEM [TIS] MODEL 030-000915
Stereotaxis, Inc.
JAA
Jun 6, 2002K021021MODULAR ANGIOGRAPHY SYSTEM AXIOM ARTIS
Siemens Medical Solutions USA, Inc.
JAA
Mar 15, 2002K020055PHILIPS INTEGRIS ALLURA 9 WITH FD OPTION
Philips Medical Systems
JAA
Oct 18, 2001K012424SHIMADZU IMAGE AMPLIFIER MODEL # IA-16LM
Shimadzu Corp.
JAA
Aug 23, 2001K010772ISI-2500 CCD C-ARM, ISI-2500 PLUS CCD C-ARM
Imaging Services, Inc.
JAA
Jun 8, 2001K011624EXPEDIO 500D R&F X-RAY SYSTEM
GE Medical Systems
JAA
Mar 12, 2001K010392ATHENA REMOTE CONTROLLED RF SYSTEM
Cares Built, Inc.
JAA
Feb 14, 2001K010187KIMAX, MODEL 1024
Medical Metrics, Inc.
JAA
Feb 2, 2001K004037X-RAY SYSTEM XR-MX
Karl Storz Endoscopy
JAA
Jun 1, 2000K000987VFSS IMAGER, MODEL SIS-300
Lifecare Imaging Intl., Ltd.
JAA
Mar 27, 2000K993896MCA-601, C-ARM MOBILE
Medison Radiology Systems, Inc.
JAA
Oct 25, 1999K992603XRT 600 R/F, WRF 0600
Wuestec Medical, Inc.
JAA
Oct 7, 1999K993038TOSHIBA RTP9211J-G11, J-ADVANCED IMAGE INTENSIFIER (I.I.)
Toshiba America Medical Systems, In.C
JAA
Feb 2, 1999K990055B-400 CEILING MOUNTED POSSITIONER, MODEL B-400
Omega Medical Imaging, Inc.
JAA
Sep 22, 1998K982319CAREGRAPH
Siemens Medical Solutions USA, Inc.
JAA
Sep 1, 1998K982345VASCO SCANNING BEAM DIGITAL X-RAY SYSTEM
Cardiac Mariners, Inc.
JAA
Jul 16, 1998K981414LC POSITIONER
Fischer Imaging Corp.
JAA
Jul 14, 1998K982028FLUOROSPOT COMPACT
Siemens Medical Solutions USA, Inc.
JAA
Jun 30, 1998K981227SYMPHONY 360 REMOTE CONTROL TABLE
Acoma Medical Imaging, Inc.
JAA
Jan 12, 1998K974058FS IV MINI C-ARM SYSTEM
Hologic, Inc.
JAA
Dec 29, 1997K973744UNICATH SP BI-PLANE (MODEL M269 & M289)
Xre Corp.
JAA
Oct 16, 1997K973067DRTS REMOTE CONTROL DRAPE
Minrad, Inc.
JAA
Oct 8, 1997K973073DRTS IMAGE INTENSIFIER DRAPE
Minrad, Inc.
JAA
Sep 11, 1997K972442CEILING MOUNTED LATERAL POSITIONER, MODEL NO. 6896.002
Continental X-Ray Corp.
JAA
May 14, 1997K970947B-350 CEILING MOUNTED C-POSITIONER
Omega Medical Imaging, Inc.
JAA
Apr 21, 1997K970608EVT MARKER BOARD
Guidant Cardiac and Vascular Surgery
JAA
Mar 28, 1997K961782BIO-BINKI
Biomni Medical Systems, Inc.
JAA
Feb 26, 1997K964990HITACHI SX-VA30 C-ARM FLUOROSCOPIC/ANGIOGRAPHIC SYSTEM (SX-VA30)
Hitachi Medical Systems America, Inc.
JAA
Feb 26, 1997K964322VIPOR UNIT
Tilane Corp.
JAA

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