FDA 510(k) Applications for Medical Device Product Code "IZH"
(System, X-Ray, Mammographic)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K023229 | AMERICAN MAMMOGRAPHICS, INC. | S.O.F.T. PADDLE (SPECIAL OPTIMIZED FULL COMPRESSION TRAY), MODEL SFT-PDLE | 12/13/2002 |
| K073262 | BEEKLEY CORP. | BELLA | 03/26/2008 |
| K020624 | BEEKLEY CORP. | BREAST BOLSTER | 09/12/2002 |
| K964576 | BENNETT X-RAY CORP. | PROFILE MAMMOGRAPHY SYSTEM (M-PRO) | 01/10/1997 |
| K003795 | BIOLUCENT, INC. | BIOLUCENT MAMMOGRAPHY CUSHION | 02/14/2001 |
| K992037 | DEL MEDICAL IMAGING CORP. | MAMEX | 07/30/1999 |
| K993681 | DIGITEC MEDICAL SERVICE CORP. | DIGITEC TWO STAGE COMPRESSION KIT | 12/21/1999 |
| K010792 | DIGITEC MEDICAL SERVICE CORP. | MAMMOGRAPH | 04/03/2001 |
| K071787 | DJA DISTRIBUTORS, LLC | BEMITT, MODEL 0001 | 10/26/2007 |
| K983313 | ELSCINT, INC. | ADVANCED AUTOMATIC DETECTOR SELECTION OPTION FOR GLORY | 12/11/1998 |
| K970680 | ELSCINT, INC. | GLORY | 06/20/1997 |
| K960381 | ELSCINT, INC. | MAM-CH22S WITH AUTOMATIC FILTER SELECTION OPTION | 04/29/1996 |
| K003473 | ELSCINTEC SYSTEMS LTD. | DIGIMAM DIGITAL STEREOTACTIC BIOPSY SYSTEM OPTION FOR GLORY MAMMOGRAPHIC SYSTEM | 11/28/2000 |
| K042095 | FISCHER IMAGING CORP. | MAMMOTEST | 10/29/2004 |
| K973400 | FISCHER IMAGING CORP. | MAMMOTEST ADAPTER DRIVER | 11/10/1997 |
| K113284 | FUJI FILM MEDICAL SYSTEMS | BIOPSY POSITIONER | 03/07/2012 |
| K191495 | FUJIFILM Corporation | Biopsy Positioner | 07/03/2019 |
| K953250 | GE MEDICAL SYSTEMS | SENOGRAPHE PEARL AND SENOGRAPHE SAPPHIRE | 01/26/1996 |
| K040125 | GE MEDICAL SYSTEMS, INC. | SENOGRAPHIC STEREO | 04/19/2004 |
| K113607 | GIOTTO USA, LLC | BIOPSY DIGIT S BIOPSY SL | 08/10/2012 |
| K062039 | GIOTTO USA, LLC | BIOPSY DIGIT-AM | 09/11/2006 |
| K161575 | HOLOGIC | Affirm Lateral Arm Upright Biopsy Accessory | 08/10/2016 |
| K153486 | Hologic Inc | Affirm Prone Biopsy System | 04/01/2016 |
| K202294 | Hologic, Inc | Affirm Contrast Biopsy | 10/05/2020 |
| K103512 | HOLOGIC, INC. | AFFIRM BREAST BIOPSY GUIDANCE SYSTEM | 01/07/2011 |
| K100692 | HOLOGIC, INC. | DIGITAL SPOT MAMMOGRAPHY SYSTEM | 04/06/2010 |
| K040884 | HOLOGIC, INC. | LORAD DIGITAL SPOT MAMMOGRAPHY SYSTEM | 04/23/2004 |
| K203509 | IMS Giotto S.p.A. | SMART FINDER | 07/14/2021 |
| K981641 | INSTRUMENTARIUM CORP. | MAMMOGRAPHY X-RAY EQUIPMENT MODELS MGF101 AND MGF110, ALPHA III, ALPHA ST, ALPHA RT AND ALPHA IQ | 07/17/1998 |
| K022275 | INSTRUMENTARIUM CORP. IMAGING DIVISION | DELTA 32; DELTA 32 TACT | 09/12/2002 |
| K023864 | INSTRUMENTARIUM CORP. IMAGING DIVISION | PERFORMA STEREO | 01/09/2003 |
| K955411 | INSTRUMENTARIUM IMAGING, INC. | DELTA 16 | 03/21/1996 |
| K001171 | INSTRUMENTARIUM IMAGING, INC. | DELTA 16 TACT | 05/12/2000 |
| K002472 | INSTRUMENTARIUM IMAGING, INC. | DELTA 32 AND DELTA 32 TACT | 11/29/2000 |
| K000976 | INSTRUMENTARIUM IMAGING, INC. | DIAMOND (MAMMOGRAPHIC X-RAY SYSTEM) | 06/01/2000 |
| K101373 | IZI MEDICAL PRODUCTS INC. | EMBRACE | 09/15/2010 |
| K973915 | KCI NEW TECHNOLOGIES, INC. | INFLATABLE POSITIONING CUSHIONS | 11/10/1997 |
| K980235 | KCI NEW TECHNOLOGIES, INC. | REMOTE HAND CONTROL TO THE INFLATABLE POSITIONING CUSHION (A.K.A. IMAGEAIR) | 04/09/1998 |
| K070344 | LIV INTERNATIONAL USA, INC. | LIV BREAST SELF EXAMINATION AID | 03/08/2007 |
| K033202 | LIVINGSTON PRODUCTS, INC. | ADVANTAGE PADDLE | 12/03/2003 |
| K992280 | LORAD CORP. | LORAD 1-650 (INTERNATIONAL 650) | 09/03/1999 |
| K973631 | LORAD CORP. | LORAD M-III ELITE (M-III E) | 12/23/1997 |
| K122836 | LORAD, A HOLOGIC CO. | AFFIRM BREAST BIOPSY GUIDANCE SYSTEM | 01/11/2013 |
| K071542 | LORAD, A HOLOGIC CO. | DIGITAL STEREOLOC II | 07/05/2007 |
| K013290 | LORAD, A HOLOGIC CO. | MODIFIED 650 MAMMOGRAPHY SYSTEM | 10/24/2001 |
| K011987 | LORAD, A HOLOGIC CO. | MODIFIED M-IV MAMMOGRAPHY SYSTEM | 07/11/2001 |
| K030666 | LORAD, A HOLOGIC CO. | MULTICARE PLATINUM SYSTEM AND ACCESSORIES | 03/25/2003 |
| K123414 | MACBRUD CORP., MEDICAL DIVISION | SPECBOARD JR. | 01/11/2013 |
| K953902 | MEDICAL MARKETING INTL., INC. | GIOTTO HIGH TECH (H.T.) MAMMOGRAPHIC SYSTEM | 03/19/1997 |
| K993740 | MEDICAL SYSTEMS GROUP | MAMEX | 11/26/1999 |
| K012953 | MEDX, INC. | GIOTTO IMAGE | 11/30/2001 |
| K973493 | PLANMED OY | PLANMED CYTOGUIDE | 11/10/1997 |
| K013656 | PLANMED OY | PLANMED SOPHIE & PLANMED SOPHIE CLASSIC | 01/16/2002 |
| K983659 | PLANMED OY | PLANMED SOPHIE & PLANNED SOPHIE CLASSIC | 11/16/1998 |
| K021945 | PLANMED OY | PLANMED SOPHIE & SOPHIE CLASSIC (WITH DIGISPOT AND CYTOGUIDE) | 02/21/2003 |
| K991826 | PLANMED OY | PLANMED SOPHIE AND SOPHIE CLASSIC | 08/10/1999 |
| K042671 | PLANMED OY | PLANMED SOPHIE NUANCE CLASSIC | 11/19/2004 |
| K010116 | PLANMED OY | PLANMED SOPHIE, PLANMED SOPHIE CLASSIC | 03/15/2001 |
| K962105 | PLANMED OY | PLANNED SOPHIED CLASSIC | 02/05/1997 |
| K161920 | PRECISION DYNAMICS CORPORATION | Comfort Cover | 07/15/2016 |
| K983621 | REMINGTON MEDICAL, INC. | NEEDLE GUIDE | 11/03/1998 |
| K031574 | S & S X-RAY PRODUCTS, INC. | SQUEEZE-EASE MAMMOGRAPHY CUSHION | 08/04/2003 |
| K961849 | SHAI SYG MOTION AND INNOVATIONS, LTD. | THE ROBOGUIDE | 08/21/1996 |
| K964069 | SIEMENS MEDICAL SOLUTIONS USA, INC. | DSBAS OPTION THE MAMMOMAT 3000 MAMMOGRAPHY X-RAY SYSTEM | 05/08/1997 |
| K003945 | SIEMENS MEDICAL SOLUTIONS USA, INC. | OPDIMA | 02/02/2001 |
| K982049 | SITCO, INC. | BIOPSY M | 07/14/1998 |
| K990192 | SITCO, INC. | BIOPSY-DIGIT | 03/12/1999 |
| K973856 | SITCO, INC. | GIOTTO HT | 11/21/1997 |
| K050663 | TRAXYZ MEDICAL, INC. | TRAXYLOC-1 SYSTEM | 04/08/2005 |
| K984091 | TREX MEDICAL CORP. | CONTOUR 2000 MAMMOGRAPHY SYSTEM, MODEL CTR- 2000 | 02/05/1999 |
| K984092 | TREX MEDICAL CORP. | PROFILE 2000 MAMMOGRAPHY SYSTEM, PRO-2000 | 02/05/1999 |
| K152038 | Women's Imaging Solutions Enterprises LLC | MammoGRIP | 12/22/2015 |
| K981470 | WORLDWIDE MEDICAL TECHNOLOGIES, LLC | WORLDWIDE MEDICAL TECHNOLOGIES NEEDLE GUIDE | 06/19/1998 |
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