FDA Product Code
FDA Product Code IZH — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Radiology
- 21 CFR Citation
- 892.1710
510(k) Clearances — 176 records · page 1 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K203509 | SMART FINDER | Ims Giotto S.P.A. | 2021-07-14 | Special | PDF ↗ |
| K202294 | Affirm Contrast Biopsy | Hologic, Inc. | 2020-10-05 | Special | PDF ↗ |
| K191495 | Biopsy Positioner | Fujifilm Corporation | 2019-07-03 | Special | PDF ↗ |
| K161575 | Affirm Lateral Arm Upright Biopsy Accessory | Hologic | 2016-08-10 | Traditional | PDF ↗ |
| K161920 | Comfort Cover | Precision Dynamics Corporation | 2016-07-15 | Traditional | PDF ↗ |
| K153486 | Affirm Prone Biopsy System | Hologic, Inc. | 2016-04-01 | Traditional | PDF ↗ |
| K152038 | MammoGRIP | Women'S Imaging Solutions Enterprises, LLC | 2015-12-22 | Traditional | PDF ↗ |
| K122836 | AFFIRM BREAST BIOPSY GUIDANCE SYSTEM | Lorad, A Hologic Co. | 2013-01-11 | Special | PDF ↗ |
| K123414 | SPECBOARD JR. | Macbrud Corp., Medical Division | 2013-01-11 | Traditional | PDF ↗ |
| K113607 | BIOPSY DIGIT S BIOPSY SL | Giotto USA, LLC | 2012-08-10 | Traditional | PDF ↗ |
| K113284 | BIOPSY POSITIONER | Fuji Film Medical Systems | 2012-03-07 | Traditional | PDF ↗ |
| K103512 | AFFIRM BREAST BIOPSY GUIDANCE SYSTEM | Hologic, Inc. | 2011-01-07 | Special | PDF ↗ |
| K101373 | EMBRACE | Izi Medical Products, Inc. | 2010-09-15 | Traditional | PDF ↗ |
| K100692 | DIGITAL SPOT MAMMOGRAPHY SYSTEM | Hologic, Inc. | 2010-04-06 | Special | PDF ↗ |
| K073262 | BELLA | Beekley Corp. | 2008-03-26 | Traditional | PDF ↗ |
| K071787 | BEMITT, MODEL 0001 | Dja Distributors, LLC | 2007-10-26 | Traditional | PDF ↗ |
| K071542 | DIGITAL STEREOLOC II | Lorad, A Hologic Co. | 2007-07-05 | Special | PDF ↗ |
| K070344 | LIV BREAST SELF EXAMINATION AID | Liv International USA, Inc. | 2007-03-08 | Traditional | PDF ↗ |
| K062039 | BIOPSY DIGIT-AM | Giotto USA, LLC | 2006-09-11 | Traditional | PDF ↗ |
| K050663 | TRAXYLOC-1 SYSTEM | Traxyz Medical, Inc. | 2005-04-08 | Traditional | PDF ↗ |
| K042671 | PLANMED SOPHIE NUANCE CLASSIC | Planmed OY | 2004-11-19 | Traditional | PDF ↗ |
| K042095 | MAMMOTEST | Fischer Imaging Corp. | 2004-10-29 | Traditional | PDF ↗ |
| K040884 | LORAD DIGITAL SPOT MAMMOGRAPHY SYSTEM | Hologic, Inc. | 2004-04-23 | Special | PDF ↗ |
| K040125 | SENOGRAPHIC STEREO | Ge Medical Systems, Inc. | 2004-04-19 | Traditional | PDF ↗ |
| K033202 | ADVANTAGE PADDLE | Livingston Products, Inc. | 2003-12-03 | Abbreviated | PDF ↗ |
| K031574 | SQUEEZE-EASE MAMMOGRAPHY CUSHION | S & S X-Ray Products, Inc. | 2003-08-04 | Traditional | PDF ↗ |
| K030666 | MULTICARE PLATINUM SYSTEM AND ACCESSORIES | Lorad, A Hologic Co. | 2003-03-25 | Special | PDF ↗ |
| K021945 | PLANMED SOPHIE & SOPHIE CLASSIC (WITH DIGISPOT AND CYTOGUIDE) | Planmed OY | 2003-02-21 | Traditional | PDF ↗ |
| K023864 | PERFORMA STEREO | Instrumentarium Corp. Imaging Division | 2003-01-09 | Traditional | PDF ↗ |
| K023229 | S.O.F.T. PADDLE (SPECIAL OPTIMIZED FULL COMPRESSION TRAY), MODEL SFT-PDLE | American Mammographics, Inc. | 2002-12-13 | Traditional | PDF ↗ |
| K020624 | BREAST BOLSTER | Beekley Corp. | 2002-09-12 | Traditional | PDF ↗ |
| K022275 | DELTA 32; DELTA 32 TACT | Instrumentarium Corp. Imaging Division | 2002-09-12 | Traditional | PDF ↗ |
| K013656 | PLANMED SOPHIE & PLANMED SOPHIE CLASSIC | Planmed OY | 2002-01-16 | Traditional | PDF ↗ |
| K012953 | GIOTTO IMAGE | Medx, Inc. | 2001-11-30 | Traditional | PDF ↗ |
| K013290 | MODIFIED 650 MAMMOGRAPHY SYSTEM | Lorad, A Hologic Co. | 2001-10-24 | Special | PDF ↗ |
| K011987 | MODIFIED M-IV MAMMOGRAPHY SYSTEM | Lorad, A Hologic Co. | 2001-07-11 | Special | PDF ↗ |
| K010792 | MAMMOGRAPH | Digitec Medical Service Corp. | 2001-04-03 | Traditional | PDF ↗ |
| K010116 | PLANMED SOPHIE, PLANMED SOPHIE CLASSIC | Planmed OY | 2001-03-15 | Traditional | PDF ↗ |
| K003795 | BIOLUCENT MAMMOGRAPHY CUSHION | Biolucent, Inc. | 2001-02-14 | Traditional | PDF ↗ |
| K003945 | OPDIMA | Siemens Medical Solutions USA, Inc. | 2001-02-02 | Traditional | PDF ↗ |
| K002472 | DELTA 32 AND DELTA 32 TACT | Instrumentarium Imaging, Inc. | 2000-11-29 | Traditional | PDF ↗ |
| K003473 | DIGIMAM DIGITAL STEREOTACTIC BIOPSY SYSTEM OPTION FOR GLORY MAMMOGRAPHIC SYSTEM | Elscintec Systems , Ltd. | 2000-11-28 | Traditional | PDF ↗ |
| K000976 | DIAMOND (MAMMOGRAPHIC X-RAY SYSTEM) | Instrumentarium Imaging, Inc. | 2000-06-01 | Traditional | PDF ↗ |
| K001171 | DELTA 16 TACT | Instrumentarium Imaging, Inc. | 2000-05-12 | Traditional | PDF ↗ |
| K993681 | DIGITEC TWO STAGE COMPRESSION KIT | Digitec Medical Service Corp. | 1999-12-21 | Traditional | PDF ↗ |
| K993740 | MAMEX | Medical Systems Group | 1999-11-26 | Special | PDF ↗ |
| K992280 | LORAD 1-650 (INTERNATIONAL 650) | Lorad Corp. | 1999-09-03 | Traditional | PDF ↗ |
| K991826 | PLANMED SOPHIE AND SOPHIE CLASSIC | Planmed OY | 1999-08-10 | Traditional | PDF ↗ |
| K992037 | MAMEX | Del Medical Imaging Corp. | 1999-07-30 | Special | PDF ↗ |
| K990192 | BIOPSY-DIGIT | Sitco, Inc. | 1999-03-12 | Traditional | PDF ↗ |
| K984091 | CONTOUR 2000 MAMMOGRAPHY SYSTEM, MODEL CTR- 2000 | Trex Medical Corp. | 1999-02-05 | Traditional | PDF ↗ |
| K984092 | PROFILE 2000 MAMMOGRAPHY SYSTEM, PRO-2000 | Trex Medical Corp. | 1999-02-05 | Traditional | PDF ↗ |
| K983313 | ADVANCED AUTOMATIC DETECTOR SELECTION OPTION FOR GLORY | Elscint, Inc. | 1998-12-11 | Traditional | PDF ↗ |
| K983659 | PLANMED SOPHIE & PLANNED SOPHIE CLASSIC | Planmed OY | 1998-11-16 | Abbreviated | PDF ↗ |
| K983621 | NEEDLE GUIDE | Remington Medical, Inc. | 1998-11-03 | Traditional | PDF ↗ |
| K981641 | MAMMOGRAPHY X-RAY EQUIPMENT MODELS MGF101 AND MGF110, ALPHA III, ALPHA ST, ALPHA RT AND ALPHA IQ | Instrumentarium Corp. | 1998-07-17 | Traditional | PDF ↗ |
| K982049 | BIOPSY M | Sitco, Inc. | 1998-07-14 | Traditional | PDF ↗ |
| K981470 | WORLDWIDE MEDICAL TECHNOLOGIES NEEDLE GUIDE | Worldwide Medical Technologies, LLC | 1998-06-19 | Traditional | PDF ↗ |
| K980235 | REMOTE HAND CONTROL TO THE INFLATABLE POSITIONING CUSHION (A.K.A. IMAGEAIR) | Kci New Technologies, Inc. | 1998-04-09 | Traditional | PDF ↗ |
| K973631 | LORAD M-III ELITE (M-III E) | Lorad Corp. | 1997-12-23 | Traditional | PDF ↗ |
| K973856 | GIOTTO HT | Sitco, Inc. | 1997-11-21 | Traditional | PDF ↗ |
| K973915 | INFLATABLE POSITIONING CUSHIONS | Kci New Technologies, Inc. | 1997-11-10 | Traditional | PDF ↗ |
| K973400 | MAMMOTEST ADAPTER DRIVER | Fischer Imaging Corp. | 1997-11-10 | Traditional | PDF ↗ |
| K973493 | PLANMED CYTOGUIDE | Planmed OY | 1997-11-10 | Traditional | PDF ↗ |
| K970680 | GLORY | Elscint, Inc. | 1997-06-20 | Traditional | PDF ↗ |
| K964069 | DSBAS OPTION THE MAMMOMAT 3000 MAMMOGRAPHY X-RAY SYSTEM | Siemens Medical Solutions USA, Inc. | 1997-05-08 | Traditional | PDF ↗ |
| K953902 | GIOTTO HIGH TECH (H.T.) MAMMOGRAPHIC SYSTEM | Medical Marketing Intl., Inc. | 1997-03-19 | Traditional | PDF ↗ |
| K962105 | PLANNED SOPHIED CLASSIC | Planmed OY | 1997-02-05 | Traditional | PDF ↗ |
| K964576 | PROFILE MAMMOGRAPHY SYSTEM (M-PRO) | Bennett X-Ray Corp. | 1997-01-10 | Traditional | PDF ↗ |
| K961849 | THE ROBOGUIDE | Shai Syg Motion and Innovations, Ltd. | 1996-08-21 | Traditional | PDF ↗ |
| K960381 | MAM-CH22S WITH AUTOMATIC FILTER SELECTION OPTION | Elscint, Inc. | 1996-04-29 | Traditional | PDF ↗ |
| K955411 | DELTA 16 | Instrumentarium Imaging, Inc. | 1996-03-21 | Traditional | PDF ↗ |
| K953250 | SENOGRAPHE PEARL AND SENOGRAPHE SAPPHIRE | GE Medical Systems | 1996-01-26 | Traditional | PDF ↗ |
| K955249 | SENSOR PAD | Inventive Products, Inc. | 1995-12-22 | Traditional | PDF ↗ |
| K954521 | MAMMOSPOT PADDLE | American Mammographics, Inc. | 1995-10-24 | Traditional | PDF ↗ |
| K952210 | LORAD STEROLOC II | Lorad Corp. | 1995-07-24 | Traditional | PDF ↗ |
| K951883 | PLANMED SOPHIE MAMMOGRAPHIC X-RAY UNIT | Planmed OY | 1995-05-24 | Traditional | PDF ↗ |
| K941191 | REAL TIME STEREOTIX | GE Medical Systems | 1995-05-11 | Traditional | PDF ↗ |
| K944978 | BENNETT X-RAY DIGITAL SPOT IMAGING SYSTEM MODEL M-DSI | Bennett X-Ray Corp. | 1995-05-03 | Traditional | PDF ↗ |
| K945962 | BENNETT X-RAY PROFILE POSITIONING PADDLE FOR MAMMOGRAPHY | Bennett X-Ray Corp. | 1995-04-03 | Traditional | PDF ↗ |
| K945241 | LORAD M-IV, LORAD M-IVI | Lorad Corp. | 1995-03-31 | Traditional | PDF ↗ |
| K945743 | PREFERENCE MAMMOGRAPHY SYSTEM | Philips Medical Systems (Cleveland), Inc. | 1995-03-31 | Traditional | PDF ↗ |
| K941353 | MAM-CH22S MAMMOGRAPHY SYSTEM WITH OPTIONAL MAMMOGUIDE STERIOTACTIC BIOPSY SYSTEM | Elscint, Inc. | 1995-03-31 | Traditional | PDF ↗ |
| K945619 | ATHENA HFX | Fischer Imaging Corp. | 1995-03-23 | Traditional | PDF ↗ |
| K950608 | DIGITAL SPOT MAMMOGRAPHY FOR STEROTACTIC APPLICATION | Lorad Corp. | 1995-03-02 | Traditional | PDF ↗ |
| K944816 | SUREVIEW MQSA OPTION KITS (MODEL NO.'S 377095 & 377096) | Philips Medical Systems (Cleveland), Inc. | 1995-02-08 | Traditional | PDF ↗ |
| K932356 | NOVA XM2 | Dynarad Corp. | 1995-02-08 | Traditional | PDF ↗ |
| K934478 | ALPHA STEREO | Instrumentarium Corp. | 1995-01-31 | Traditional | PDF ↗ |
| K945496 | MAMMOGRAPHIC X-RAY UNIT | Lorad Corp. | 1994-12-27 | Traditional | PDF ↗ |
| K945272 | RHODIUM FILTER | Lorad Corp. | 1994-12-14 | Traditional | PDF ↗ |
| K935428 | BENNETT X-RAY DIGITAL SPOT IMAGER | Bennett X-Ray Technologies | 1994-11-01 | Traditional | PDF ↗ |
| K934868 | LORAD TRANSPO | Lorad Corp. | 1994-10-14 | Traditional | PDF ↗ |
| K933430 | CYTOGUIDE STEREOTATIC BIOPSY SYSTEM | Gold Coast Imaging, Inc. | 1994-09-22 | Traditional | PDF ↗ |
| K932672 | MAMMOMAT 300 AND MAMMOMAT 3000 | Siemens Medical Solutions USA, Inc. | 1994-09-14 | Traditional | PDF ↗ |
| K934831 | ADVANCED AUTOMATIC KV | Elscint, Inc. | 1994-08-23 | Traditional | PDF ↗ |
| K935608 | MAMOSPAT | E.V.S. Tool & Die Co., Inc. | 1994-05-17 | Traditional | PDF ↗ |
| K936161 | SYSTEM, X-RAY, MAMOGRAPHIC | Technowipe | 1994-05-04 | Traditional | PDF ↗ |
| K940701 | BENNETT MAMMOGRAPHY POSITIONING CHAIR MODEL NO. M-PCH | Bennett X-Ray Corp. | 1994-04-28 | Traditional | PDF ↗ |
| K934373 | MOBILE SOPHIE MODIFICATION | Planmed OY | 1994-04-07 | Traditional | PDF ↗ |
| K934870 | LORAD D-550 | Lorad Corp. | 1994-01-31 | Traditional | PDF ↗ |
Product code IZH · Class II · Radiology. Data: openFDA.