System, X-Ray, Mammographic
Regulation 892.1710
0510(k)s in 12 months (176 all time)
0recalls in 12 months (14 all time)
12recalls that name a 510(k)
Top companies in IZH
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 14, 2021 | K203509 | SMART FINDER Ims Giotto S.P.A., IT | IZH |
| Oct 5, 2020 | K202294 | Affirm Contrast Biopsy Hologic, Inc. | IZH |
| Jul 3, 2019 | K191495 | Biopsy Positioner Fujifilm Corporation, JP | IZH |
| Aug 10, 2016 | K161575 | Affirm Lateral Arm Upright Biopsy Accessory Hologic | IZH |
| Jul 15, 2016 | K161920 | Comfort Cover Precision Dynamics Corporation | IZH |
| Apr 1, 2016 | K153486 | Affirm Prone Biopsy System Hologic, Inc. | IZH |
| Dec 22, 2015 | K152038 | MammoGRIP Women'S Imaging Solutions Enterprises, LLC | IZH |
| Jan 11, 2013 | K123414 | SPECBOARD JR. Macbrud Corp., Medical Division | IZH |
| Jan 11, 2013 | K122836 | AFFIRM BREAST BIOPSY GUIDANCE SYSTEM Lorad, A Hologic Co. | IZH |
| Aug 10, 2012 | K113607 | BIOPSY DIGIT S BIOPSY SL Giotto USA, LLC | IZH |
| Mar 7, 2012 | K113284 | BIOPSY POSITIONER Fuji Film Medical Systems | IZH |
| Jan 7, 2011 | K103512 | AFFIRM BREAST BIOPSY GUIDANCE SYSTEM Hologic, Inc. | IZH |
| Sep 15, 2010 | K101373 | EMBRACE Izi Medical Products, Inc. | IZH |
| Apr 6, 2010 | K100692 | DIGITAL SPOT MAMMOGRAPHY SYSTEM Hologic, Inc. | IZH |
| Mar 26, 2008 | K073262 | BELLA Beekley Corp. | IZH |
| Oct 26, 2007 | K071787 | BEMITT, MODEL 0001 Dja Distributors, LLC | IZH |
| Jul 5, 2007 | K071542 | DIGITAL STEREOLOC II Lorad, A Hologic Co. | IZH |
| Mar 8, 2007 | K070344 | LIV BREAST SELF EXAMINATION AID Liv International USA, Inc. | IZH |
| Sep 11, 2006 | K062039 | BIOPSY DIGIT-AM Giotto USA, LLC | IZH |
| Apr 8, 2005 | K050663 | TRAXYLOC-1 SYSTEM Traxyz Medical, Inc. | IZH |
| Nov 19, 2004 | K042671 | PLANMED SOPHIE NUANCE CLASSIC Planmed OY | IZH |
| Oct 29, 2004 | K042095 | MAMMOTEST Fischer Imaging Corp. | IZH |
| Apr 23, 2004 | K040884 | LORAD DIGITAL SPOT MAMMOGRAPHY SYSTEM Hologic, Inc. | IZH |
| Apr 19, 2004 | K040125 | SENOGRAPHIC STEREO Ge Medical Systems, Inc. | IZH |
| Dec 3, 2003 | K033202 | ADVANTAGE PADDLE Livingston Products, Inc. | IZH |
| Aug 4, 2003 | K031574 | SQUEEZE-EASE MAMMOGRAPHY CUSHION S & S X-Ray Products, Inc. | IZH |
| Mar 25, 2003 | K030666 | MULTICARE PLATINUM SYSTEM AND ACCESSORIES Lorad, A Hologic Co. | IZH |
| Feb 21, 2003 | K021945 | PLANMED SOPHIE & SOPHIE CLASSIC (WITH DIGISPOT AND CYTOGUIDE) Planmed OY | IZH |
| Jan 9, 2003 | K023864 | PERFORMA STEREO Instrumentarium Corp. Imaging Division | IZH |
| Dec 13, 2002 | K023229 | S.O.F.T. PADDLE (SPECIAL OPTIMIZED FULL COMPRESSION TRAY), MODEL SFT-PDLE American Mammographics, Inc. | IZH |
| Sep 12, 2002 | K022275 | DELTA 32; DELTA 32 TACT Instrumentarium Corp. Imaging Division | IZH |
| Sep 12, 2002 | K020624 | BREAST BOLSTER Beekley Corp. | IZH |
| Jan 16, 2002 | K013656 | PLANMED SOPHIE & PLANMED SOPHIE CLASSIC Planmed OY | IZH |
| Nov 30, 2001 | K012953 | GIOTTO IMAGE Medx, Inc. | IZH |
| Oct 24, 2001 | K013290 | MODIFIED 650 MAMMOGRAPHY SYSTEM Lorad, A Hologic Co. | IZH |
| Jul 11, 2001 | K011987 | MODIFIED M-IV MAMMOGRAPHY SYSTEM Lorad, A Hologic Co. | IZH |
| Apr 3, 2001 | K010792 | MAMMOGRAPH Digitec Medical Service Corp. | IZH |
| Mar 15, 2001 | K010116 | PLANMED SOPHIE, PLANMED SOPHIE CLASSIC Planmed OY | IZH |
| Feb 14, 2001 | K003795 | BIOLUCENT MAMMOGRAPHY CUSHION Biolucent, Inc. | IZH |
| Feb 2, 2001 | K003945 | OPDIMA Siemens Medical Solutions USA, Inc. | IZH |
| Nov 29, 2000 | K002472 | DELTA 32 AND DELTA 32 TACT Instrumentarium Imaging, Inc. | IZH |
| Nov 28, 2000 | K003473 | DIGIMAM DIGITAL STEREOTACTIC BIOPSY SYSTEM OPTION FOR GLORY MAMMOGRAPHIC SYSTEM Elscintec Systems , Ltd., IL | IZH |
| Jun 1, 2000 | K000976 | DIAMOND (MAMMOGRAPHIC X-RAY SYSTEM) Instrumentarium Imaging, Inc. | IZH |
| May 12, 2000 | K001171 | DELTA 16 TACT Instrumentarium Imaging, Inc. | IZH |
| Dec 21, 1999 | K993681 | DIGITEC TWO STAGE COMPRESSION KIT Digitec Medical Service Corp. | IZH |
| Nov 26, 1999 | K993740 | MAMEX Medical Systems Group | IZH |
| Sep 3, 1999 | K992280 | LORAD 1-650 (INTERNATIONAL 650) Lorad Corp. | IZH |
| Aug 10, 1999 | K991826 | PLANMED SOPHIE AND SOPHIE CLASSIC Planmed OY | IZH |
| Jul 30, 1999 | K992037 | MAMEX Del Medical Imaging Corp. | IZH |
| Mar 12, 1999 | K990192 | BIOPSY-DIGIT Sitco, Inc. | IZH |
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