Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
IZH — Predicate Candidate Screening
176 FDA 510(k) clearances under this product code; the 50 most recent screened below.
77 daysmedian FDA review time
227 days90th percentile
176clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K203509 | SMART FINDER | Ims Giotto S.P.A. | 2021-07-14 | 226 | 0 |
| K202294 | Affirm Contrast Biopsy | Hologic, Inc. | 2020-10-05 | 53 | 0 |
| K191495 | Biopsy Positioner | Fujifilm Corporation | 2019-07-03 | 28 | 0 |
| K161575 | Affirm Lateral Arm Upright Biopsy Accessory | Hologic | 2016-08-10 | 64 | 0 |
| K161920 | Comfort Cover | Precision Dynamics Corporation | 2016-07-15 | 2 | 0 |
| K153486 | Affirm Prone Biopsy System | Hologic, Inc. | 2016-04-01 | 119 | 0 |
| K152038 | MammoGRIP | Women'S Imaging Solutions Enterprises, LLC | 2015-12-22 | 153 | 0 |
| K122836 | AFFIRM BREAST BIOPSY GUIDANCE SYSTEM | Lorad, A Hologic Co. | 2013-01-11 | 116 | 0 |
| K123414 | SPECBOARD JR. | Macbrud Corp., Medical Division | 2013-01-11 | 66 | 0 |
| K113607 | BIOPSY DIGIT S BIOPSY SL | Giotto USA, LLC | 2012-08-10 | 248 | 0 |
| K113284 | BIOPSY POSITIONER | Fuji Film Medical Systems | 2012-03-07 | 121 | 0 |
| K103512 | AFFIRM BREAST BIOPSY GUIDANCE SYSTEM | Hologic, Inc. | 2011-01-07 | 38 | 0 |
| K101373 | EMBRACE | Izi Medical Products, Inc. | 2010-09-15 | 121 | 0 |
| K100692 | DIGITAL SPOT MAMMOGRAPHY SYSTEM | Hologic, Inc. | 2010-04-06 | 27 | 0 |
| K073262 | BELLA | Beekley Corp. | 2008-03-26 | 127 | 0 |
| K071787 | BEMITT, MODEL 0001 | Dja Distributors, LLC | 2007-10-26 | 116 | 0 |
| K071542 | DIGITAL STEREOLOC II | Lorad, A Hologic Co. | 2007-07-05 | 30 | 0 |
| K070344 | LIV BREAST SELF EXAMINATION AID | Liv International USA, Inc. | 2007-03-08 | 30 | 0 |
| K062039 | BIOPSY DIGIT-AM | Giotto USA, LLC | 2006-09-11 | 54 | 0 |
| K050663 | TRAXYLOC-1 SYSTEM | Traxyz Medical, Inc. | 2005-04-08 | 24 | 0 |
| K042671 | PLANMED SOPHIE NUANCE CLASSIC | Planmed OY | 2004-11-19 | 51 | 0 |
| K042095 | MAMMOTEST | Fischer Imaging Corp. | 2004-10-29 | 87 | 1 |
| K040884 | LORAD DIGITAL SPOT MAMMOGRAPHY SYSTEM | Hologic, Inc. | 2004-04-23 | 18 | 0 |
| K040125 | SENOGRAPHIC STEREO | Ge Medical Systems, Inc. | 2004-04-19 | 90 | 0 |
| K033202 | ADVANTAGE PADDLE | Livingston Products, Inc. | 2003-12-03 | 62 | 0 |
| K031574 | SQUEEZE-EASE MAMMOGRAPHY CUSHION | S & S X-Ray Products, Inc. | 2003-08-04 | 76 | 0 |
| K030666 | MULTICARE PLATINUM SYSTEM AND ACCESSORIES | Lorad, A Hologic Co. | 2003-03-25 | 22 | 0 |
| K021945 | PLANMED SOPHIE & SOPHIE CLASSIC (WITH DIGISPOT AND CYTOGUIDE | Planmed OY | 2003-02-21 | 253 | 0 |
| K023864 | PERFORMA STEREO | Instrumentarium Corp. Imaging Division | 2003-01-09 | 50 | 0 |
| K023229 | S.O.F.T. PADDLE (SPECIAL OPTIMIZED FULL COMPRESSION TRAY), M | American Mammographics, Inc. | 2002-12-13 | 77 | 0 |
| K020624 | BREAST BOLSTER | Beekley Corp. | 2002-09-12 | 198 | 0 |
| K022275 | DELTA 32; DELTA 32 TACT | Instrumentarium Corp. Imaging Division | 2002-09-12 | 59 | 0 |
| K013656 | PLANMED SOPHIE & PLANMED SOPHIE CLASSIC | Planmed OY | 2002-01-16 | 71 | 0 |
| K012953 | GIOTTO IMAGE | Medx, Inc. | 2001-11-30 | 87 | 0 |
| K013290 | MODIFIED 650 MAMMOGRAPHY SYSTEM | Lorad, A Hologic Co. | 2001-10-24 | 22 | 0 |
| K011987 | MODIFIED M-IV MAMMOGRAPHY SYSTEM | Lorad, A Hologic Co. | 2001-07-11 | 15 | 3 |
| K010792 | MAMMOGRAPH | Digitec Medical Service Corp. | 2001-04-03 | 18 | 0 |
| K010116 | PLANMED SOPHIE, PLANMED SOPHIE CLASSIC | Planmed OY | 2001-03-15 | 58 | 0 |
| K003795 | BIOLUCENT MAMMOGRAPHY CUSHION | Biolucent, Inc. | 2001-02-14 | 68 | 0 |
| K003945 | OPDIMA | Siemens Medical Solutions USA, Inc. | 2001-02-02 | 43 | 0 |
| K002472 | DELTA 32 AND DELTA 32 TACT | Instrumentarium Imaging, Inc. | 2000-11-29 | 110 | 0 |
| K003473 | DIGIMAM DIGITAL STEREOTACTIC BIOPSY SYSTEM OPTION FOR GLORY | Elscintec Systems , Ltd. | 2000-11-28 | 20 | 0 |
| K000976 | DIAMOND (MAMMOGRAPHIC X-RAY SYSTEM) | Instrumentarium Imaging, Inc. | 2000-06-01 | 66 | 1 |
| K001171 | DELTA 16 TACT | Instrumentarium Imaging, Inc. | 2000-05-12 | 31 | 0 |
| K993681 | DIGITEC TWO STAGE COMPRESSION KIT | Digitec Medical Service Corp. | 1999-12-21 | 50 | 0 |
| K993740 | MAMEX | Medical Systems Group | 1999-11-26 | 22 | 0 |
| K992280 | LORAD 1-650 (INTERNATIONAL 650) | Lorad Corp. | 1999-09-03 | 58 | 0 |
| K991826 | PLANMED SOPHIE AND SOPHIE CLASSIC | Planmed OY | 1999-08-10 | 74 | 0 |
| K992037 | MAMEX | Del Medical Imaging Corp. | 1999-07-30 | 44 | 0 |
| K990192 | BIOPSY-DIGIT | Sitco, Inc. | 1999-03-12 | 50 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda