FDA 510(k) Applications for Medical Device Product Code "JAA"
(System, X-Ray, Fluoroscopic, Image-Intensified)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K981227 | ACOMA MEDICAL IMAGING, INC. | SYMPHONY 360 REMOTE CONTROL TABLE | 06/30/1998 |
| K180589 | Agfa HealthCare N.V. | DR 800 with MUSICA Dynamic | 04/05/2018 |
| K212145 | Agfa N.V. | DR 800 with DSA, DR 800 | 08/31/2021 |
| K131766 | APELEM-DMS GROUP | PLATINUM DRF IMAGING SYSTEM | 12/12/2013 |
| K203010 | Apelem-DMS Group | Platinum dRF Imaging System | 01/22/2021 |
| K160301 | Apelem-DMS Group | Platinum dRF Imaging System | 03/04/2016 |
| K961782 | BIOMNI MEDICAL SYSTEMS, INC. | BIO-BINKI | 03/28/1997 |
| K232526 | Canon Medical Systems Corporation | XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.5 | 09/12/2023 |
| K953113 | CARDIAC MARINERS, INC. | SBDX MOBILE FLUOROSCOPY SYSTEM | 03/29/1996 |
| K982345 | CARDIAC MARINERS, INC. | VASCO SCANNING BEAM DIGITAL X-RAY SYSTEM | 09/01/1998 |
| K010392 | CARES BUILT, INC. | ATHENA REMOTE CONTROLLED RF SYSTEM | 03/12/2001 |
| K202235 | CMT Medical Technologies Ltd | ArtPIX DRF | 09/03/2020 |
| K103038 | CMT MEDICAL TECHNOLOGIES, LTD. | DUET DRF | 03/29/2011 |
| K961140 | CMT MEDICAL TECHNOLOGIES, LTD. | FLUOROPLUS CARDIAC TV | 09/20/1996 |
| K961690 | CONTINENTAL X-RAY CORP. | CARDIOARC SERIES: POSITIONER C-ARM MODELS NO. 6896.001 AND 6896.105 | 06/27/1996 |
| K972442 | CONTINENTAL X-RAY CORP. | CEILING MOUNTED LATERAL POSITIONER, MODEL NO. 6896.002 | 09/11/1997 |
| K962140 | CONTINENTAL X-RAY CORP. | ICT-2000, INTEGRATED C-ARM/TABLE MULTIPURPOSE RADIOGRAPHIC/FLUOROSCOPIC POSITIONING SYSTEM MODEL NO. 6896.300 | 07/25/1996 |
| K955687 | CONTOUR FABRICATORS OF FLORIDA, INC. | RNS STERILE, DISPOSABLE RADIOGRAPHIC CONTRAST TRAY | 06/03/1996 |
| K220871 | Dornier MedTech America, Inc | Nautilus | 04/18/2022 |
| K151485 | DORNIER MEDTECH AMERICA, INC. | GENESIS | 06/30/2015 |
| K122768 | DORNIER MEDTECH AMERICA, INC. | GENESIS | 01/18/2013 |
| K133434 | DORNIER MEDTECH AMERICA, INC. | GENESIS II | 11/26/2014 |
| K954945 | F. WALTER HANEL GMBH | HANEL MAVIG MONITOR SUSPENSION SYSTEM | 01/29/1996 |
| K961207 | FISCHER IMAGING CORP. | EP-X BIPLANE | 08/20/1996 |
| K981414 | FISCHER IMAGING CORP. | LC POSITIONER | 07/16/1998 |
| K081091 | GE HEALTHCARE | PRECISION 500D R&F X-RAY SYSTEM | 06/11/2008 |
| K011624 | GE MEDICAL SYSTEMS | EXPEDIO 500D R&F X-RAY SYSTEM | 06/08/2001 |
| K061028 | GE MEDICAL SYSTEMS, LLC | PRECISION THUNIS 800+ | 06/07/2006 |
| K024012 | GE OEC MEDICAL SYSTEMS | OEC 9800 E/CV+ DIGITAL MOBILE IMAGING SYSTEM | 03/20/2003 |
| K132289 | GEMSS MEDICAL SYSTEMS CO. LTD | GEMSS MEDICAL SYSTEMS SURGICAL MOBILE FLUOROSCOPIC X-RAY SYSTEM | 06/16/2014 |
| K173395 | General Medical Merate S.P.A | MECALL CLISIS SYSTEMS, Discovery RF180 | 05/21/2018 |
| K140380 | GENERAL MEDICAL MERATE S.P.A. | OPERA SWING | 09/26/2014 |
| K970608 | GUIDANT CARDIAC AND VASCULAR SURGERY | EVT MARKER BOARD | 04/21/1997 |
| K964990 | HITACHI MEDICAL SYSTEMS AMERICA, INC. | HITACHI SX-VA30 C-ARM FLUOROSCOPIC/ANGIOGRAPHIC SYSTEM (SX-VA30) | 02/26/1997 |
| K051025 | HOLOGIC, INC. | FLUOROSCAN INSIGHT MINI C-ARM FLUOROSCOPIC IMAGING SYSTEM | 05/13/2005 |
| K974058 | HOLOGIC, INC. | FS IV MINI C-ARM SYSTEM | 01/12/1998 |
| K962606 | I.Z.I. MEDICAL PRODUCTS CORP. | TOPOGRAPHIC IMAGING MARKER | 08/07/1996 |
| K210469 | Imaging Engineering, LLC | Insight Agile DRF | 07/27/2021 |
| K200396 | Imaging Engineering, LLC | Insight Enhanced DRF Digital Imaging System | 03/06/2020 |
| K191310 | Imaging Engineering, LLC | Insight Essentials DRF Digital Imaging System | 06/10/2019 |
| K010772 | IMAGING SERVICES, INC. | ISI-2500 CCD C-ARM, ISI-2500 PLUS CCD C-ARM | 08/23/2001 |
| K022911 | INTEGRITY PRACTICE MANAGEMENT, INC. | MODEL AMI1200 C-ARM | 12/02/2002 |
| K004037 | KARL STORZ ENDOSCOPY | X-RAY SYSTEM XR-MX | 02/02/2001 |
| K200965 | KARL STORZ Endoscopy America, Inc. | XR-MX/1000 | 12/29/2020 |
| K052610 | LAKESHORE TECHNOLOGIES INC. | IMAGE STAR II | 11/30/2005 |
| K000987 | LIFECARE IMAGING INTL., LTD. | VFSS IMAGER, MODEL SIS-300 | 06/01/2000 |
| K010187 | MEDICAL METRICS, INC. | KIMAX, MODEL 1024 | 02/14/2001 |
| K993896 | MEDISON RADIOLOGY SYSTEMS, INC. | MCA-601, C-ARM MOBILE | 03/27/2000 |
| K953974 | MEDIVISION MEDICAL IMAGING, LTD. | CAMVISION 1000 | 09/09/1996 |
| K973073 | MINRAD, INC. | DRTS IMAGE INTENSIFIER DRAPE | 10/08/1997 |
| K973067 | MINRAD, INC. | DRTS REMOTE CONTROL DRAPE | 10/16/1997 |
| K951261 | NICAL | DFI-1000 AND DVS-475 IMAGING DEVICES | 03/15/1996 |
| K970947 | OMEGA MEDICAL IMAGING, INC. | B-350 CEILING MOUNTED C-POSITIONER | 05/14/1997 |
| K990055 | OMEGA MEDICAL IMAGING, INC. | B-400 CEILING MOUNTED POSSITIONER, MODEL B-400 | 02/02/1999 |
| K191713 | Omega Medical Imaging, LLC | CS-series-FP Radiographic / Fluoroscopic Systems with Optional CA-100S / FluoroShieldÖ (ROI Assembly) | 10/04/2019 |
| K121293 | OMEGA MEDICAL IMAGING, LLC | CS-SERIES-FP WITH 3030+OPTION | 07/26/2012 |
| K182834 | Omega Medical Imaging, LLC | CS-series-FP with Optional ROI Accessory CA-100S | 03/29/2019 |
| K212890 | Omega Medical Imaging, LLC | Nyquist.IQ | 12/13/2021 |
| K050866 | OSTEOSYS CO., LTD. | CENTRION 500 C-ARM SYSTEM | 04/27/2005 |
| K161019 | PAUSCH MEDICAL GMBH | Uroview FD | 08/17/2016 |
| K180651 | Pausch Medical GmbH | Uroview FD II | 04/12/2018 |
| K020055 | PHILIPS MEDICAL SYSTEMS | PHILIPS INTEGRIS ALLURA 9 WITH FD OPTION | 03/15/2002 |
| K203087 | Philips Medical Systems DMC GmbH | CombiDiagnost R90 | 12/03/2020 |
| K163210 | Philips Medical Systems DMC GmbH | Philips CombiDiagnost R90 | 01/31/2017 |
| K212837 | Philips Medical Systems DMC GmbH | ProxiDiagnost N90 | 09/21/2021 |
| K050692 | PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO. | FLXIS | 04/08/2005 |
| K022899 | PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO. | PHILIPS INTEGRIS ALLURA FLAT DETECTOR RELEASE 1.0 | 11/22/2002 |
| K191504 | Radiology Information Systems, Inc. | PowerDR | 08/16/2019 |
| K012424 | SHIMADZU CORP. | SHIMADZU IMAGE AMPLIFIER MODEL # IA-16LM | 10/18/2001 |
| K040870 | SHIMADZU CORP. | SHIMADZU IMAGE AMPLIFIER, MODEL IA-16L/HS | 05/17/2004 |
| K131075 | SHIMADZU CORP. | X-RAY TV SYSTEM SONIAL VISION G4 | 03/28/2014 |
| K142341 | SHIMADZU CORP. | X-RAY TV SYSTEM SONIALVISION G4 | 03/06/2015 |
| K191877 | Shimadzu Corporation | FLUOROspeed | 08/05/2019 |
| K190373 | SHIMADZU corporation | SonialVision G4 | 03/15/2019 |
| K963888 | SHIMADZU MEDICAL SYSTEMS | C-ARM TABLE IVS-100 | 12/18/1996 |
| K963617 | SHIMADZU MEDICAL SYSTEMS | SHIMADZU X-RAY DIAGNOSTIC TABLE YSF-120 | 11/08/1996 |
| K982319 | SIEMENS MEDICAL SOLUTIONS USA, INC. | CAREGRAPH | 09/22/1998 |
| K982028 | SIEMENS MEDICAL SOLUTIONS USA, INC. | FLUOROSPOT COMPACT | 07/14/1998 |
| K111292 | SIEMENS MEDICAL SOLUTIONS USA, INC. | LUMINOS AGILE | 06/03/2011 |
| K021021 | SIEMENS MEDICAL SOLUTIONS USA, INC. | MODULAR ANGIOGRAPHY SYSTEM AXIOM ARTIS | 06/06/2002 |
| K960266 | SIEMENS MEDICAL SOLUTIONS USA, INC. | SIREGRAPH CF | 03/11/1996 |
| K101491 | SIEMENS MEDICAL SOLUTIONS USA, INC. | UROSKOP OMNIA | 06/30/2010 |
| K051602 | SIEMENS MEDICAL SYSTEMS, INC. | AXIOM SIRESKOP SD | 07/07/2005 |
| K081491 | SMITH & NEPHEW, INC. | SMITH & NEPHEW CDS SYSTEM | 06/19/2008 |
| K051136 | SMITH & NEPHEW, INC. | SMITH & NEPHEW CDS SYSTEM | 07/01/2005 |
| K150306 | STEPHANIX RADIOLOGICAL SOLUTIONS | D2RS_AT Digital Dynamic Remote System | 10/10/2015 |
| K022565 | STEREOTAXIS, INC. | TELSTAR BIPLANE DIGITAL IMAGING SYSTEM [TIS] MODEL 030-000915 | 10/08/2002 |
| K964322 | TILANE CORP. | VIPOR UNIT | 02/26/1997 |
| K123097 | TOSHIBA AMERICA MEDICAL SYSTEMS, INC. | DOSE TRACKING SYSTEM MODEL XIDF-DTS801 | 02/13/2013 |
| K132106 | TOSHIBA AMERICA MEDICAL SYSTEMS, INC. | INFINIX ANGIO WORKSTATION W/DTS SOFTWARE | 11/12/2013 |
| K081621 | TOSHIBA AMERICA MEDICAL SYSTEMS, INC. | INFX-8000C (INFINIX CC-I AND VC-I) | 06/23/2008 |
| K082830 | TOSHIBA AMERICA MEDICAL SYSTEMS, INC. | INFX-8000H, INFINIX-I | 10/10/2008 |
| K081582 | TOSHIBA AMERICA MEDICAL SYSTEMS, INC. | INFX-8000V, INFINIX-CFI AND INFINIX VFI | 06/17/2008 |
| K133553 | TOSHIBA AMERICA MEDICAL SYSTEMS, INC. | KALARE | 06/13/2014 |
| K993038 | TOSHIBA AMERICA MEDICAL SYSTEMS, INC. | TOSHIBA RTP9211J-G11, J-ADVANCED IMAGE INTENSIFIER (I.I.) | 10/07/1999 |
| K110785 | TOSHIBA MEDICAL SYSTEMS COPORATION, JAPAN | KALARE DIAGNOSTIC X-RAY TABLE SYSTEM | 05/27/2011 |
| K141541 | TOSHIBA MEDICAL SYSTEMS CORPORATION | XIDF-AWS801, ANGIO WORKSTATION, V5.31 | 09/08/2014 |
| K112054 | TOSHIBA MEDICAL SYSTEMS CORPORATION, JAPAN | INFINIX CF-I/SP AND INFINIX VF-I/SP MODEL INFX-8000V | 08/05/2011 |
| K042698 | UNFORS INC. | UNFORS PATIENT SKIN DOSIMETER (PSD) | 10/22/2004 |
| K130318 | VARIAN MEDICAL SYSTEMS, X-RAY PRODUCTS-INFIMED | NEXUS DRF DIGITAL X-RAY IMAGING SYSTEM (WITH PAXSCAN 4343CB) | 04/22/2013 |
| K080859 | VILLA SISTEMI MEDICALI S.P.A. | DRF 4343 | 06/04/2008 |
| K070390 | VIRTUAL IMAGING, INC. | FLUOROPRO RF DIGITAL IMAGING SYSTEM | 04/05/2007 |
| K992603 | WUESTEC MEDICAL, INC. | XRT 600 R/F, WRF 0600 | 10/25/1999 |
| K961193 | XRE CORP. | FULL FRAME ZOOM SYSTEM | 06/17/1996 |
| K973744 | XRE CORP. | UNICATH SP BI-PLANE (MODEL M269 & M289) | 12/29/1997 |
| K132904 | ZIEHM IMAGING GMBH | ZIEHM VISION RFD | 12/05/2013 |
| K203428 | Ziehm Imaging GmbH | Ziehm Vision RFD | 03/17/2021 |
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