Product code IZH
- Device name
- System, X-Ray, Mammographic
- Medical specialty
- Radiology
- Device class
- 2
- Regulation number
- 892.1710
- Review panel
- RA
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K203509 | SMART FINDER | Ims Giotto S.P.A. | 2021-07-14 |
| K202294 | Affirm Contrast Biopsy | Hologic, Inc. | 2020-10-05 |
| K191495 | Biopsy Positioner | Fujifilm Corporation | 2019-07-03 |
| K161575 | Affirm Lateral Arm Upright Biopsy Accessory | Hologic | 2016-08-10 |
| K161920 | Comfort Cover | Precision Dynamics Corporation | 2016-07-15 |
| K153486 | Affirm Prone Biopsy System | Hologic, Inc. | 2016-04-01 |
| K152038 | MammoGRIP | Women'S Imaging Solutions Enterprises, LLC | 2015-12-22 |
| K123414 | SPECBOARD JR. | Macbrud Corp., Medical Division | 2013-01-11 |
| K122836 | AFFIRM BREAST BIOPSY GUIDANCE SYSTEM | Lorad, A Hologic Co. | 2013-01-11 |
| K113607 | BIOPSY DIGIT S BIOPSY SL | Giotto USA, LLC | 2012-08-10 |
| K113284 | BIOPSY POSITIONER | Fuji Film Medical Systems | 2012-03-07 |
| K103512 | AFFIRM BREAST BIOPSY GUIDANCE SYSTEM | Hologic, Inc. | 2011-01-07 |
| K101373 | EMBRACE | Izi Medical Products, Inc. | 2010-09-15 |
| K100692 | DIGITAL SPOT MAMMOGRAPHY SYSTEM | Hologic, Inc. | 2010-04-06 |
| K073262 | BELLA | Beekley Corp. | 2008-03-26 |
| K071787 | BEMITT, MODEL 0001 | Dja Distributors, LLC | 2007-10-26 |
| K071542 | DIGITAL STEREOLOC II | Lorad, A Hologic Co. | 2007-07-05 |
| K070344 | LIV BREAST SELF EXAMINATION AID | Liv International USA, Inc. | 2007-03-08 |
| K062039 | BIOPSY DIGIT-AM | Giotto USA, LLC | 2006-09-11 |
| K050663 | TRAXYLOC-1 SYSTEM | Traxyz Medical, Inc. | 2005-04-08 |
| K042671 | PLANMED SOPHIE NUANCE CLASSIC | Planmed OY | 2004-11-19 |
| K042095 | MAMMOTEST | Fischer Imaging Corp. | 2004-10-29 |
| K040884 | LORAD DIGITAL SPOT MAMMOGRAPHY SYSTEM | Hologic, Inc. | 2004-04-23 |
| K040125 | SENOGRAPHIC STEREO | Ge Medical Systems, Inc. | 2004-04-19 |
| K033202 | ADVANTAGE PADDLE | Livingston Products, Inc. | 2003-12-03 |
| K031574 | SQUEEZE-EASE MAMMOGRAPHY CUSHION | S & S X-Ray Products, Inc. | 2003-08-04 |
| K030666 | MULTICARE PLATINUM SYSTEM AND ACCESSORIES | Lorad, A Hologic Co. | 2003-03-25 |
| K021945 | PLANMED SOPHIE & SOPHIE CLASSIC (WITH DIGISPOT AND CYTOGUIDE) | Planmed OY | 2003-02-21 |
| K023864 | PERFORMA STEREO | Instrumentarium Corp. Imaging Division | 2003-01-09 |
| K023229 | S.O.F.T. PADDLE (SPECIAL OPTIMIZED FULL COMPRESSION TRAY), MODEL SFT-PDLE | American Mammographics, Inc. | 2002-12-13 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 15420045518292 | Affirm Prone Biopsy System | Hologic, Inc. | 2026-03-12 |
| 15420045518285 | Affirm Prone Biopsy System | Hologic, Inc. | 2026-03-12 |
| 15420045518278 | Affirm Prone Biopsy System | Hologic, Inc. | 2026-03-12 |
| 15420045518261 | Affirm Prone Biopsy System | Hologic, Inc. | 2026-03-12 |
| 15420045518247 | Affirm Prone Biopsy System | Hologic, Inc. | 2026-03-12 |
| 15420045518087 | Affirm® | Hologic, Inc. | 2025-07-17 |
| 08056977360113 | SMART FINDER | IMS GIOTTO SPA | 2023-06-25 |
| 15420045512931 | AFFIRM™ SPECIMEN IMAGING | Hologic, Inc. | 2021-07-10 |
| 15420045512948 | AFFIRM™ CONTRAST BIOPSY | Hologic, Inc. | 2020-11-18 |
| 00813079020417 | Closed Needle Guide | REMINGTON MEDICAL, INC. | 2020-09-24 |
| 00813079020424 | Open Needle Guide | REMINGTON MEDICAL, INC. | 2020-09-24 |
| 00813079020400 | Closed Needle Guide | REMINGTON MEDICAL, INC. | 2020-09-24 |
| 10813079020407 | Closed Needle Guide | REMINGTON MEDICAL, INC. | 2020-09-24 |
| 20813079020411 | Closed Needle Guide | REMINGTON MEDICAL, INC. | 2020-09-24 |
| 10813079020421 | Open Needle Guide | REMINGTON MEDICAL, INC. | 2020-09-24 |
| B852SPECBOARD2220 | SPECBOARD JR | MACBRUD CORPORATION | 2020-03-18 |
| B852SPECBOARD4440 | Specboard | MACBRUD CORPORATION | 2020-03-18 |
| 15420045510852 | Affirm Prone Biopsy System | Hologic, Inc. | 2019-09-19 |
| 15420045510845 | Affirm Prone Biopsy System | Hologic, Inc. | 2019-09-19 |
| 00840682123297 | Senographe Essential Stereotaxy | GE MEDICAL SYSTEMS | 2016-12-29 |
| 04547410336047 | FDR-2000BPY | FUJIFILM CORPORATION | 2016-12-14 |
| 04547410327342 | FDR-2000BPY | FUJIFILM CORPORATION | 2016-12-14 |
| 08033837190301 | MAMMOBED | I.M.S. INTERNAZIONALE MEDICO SCIENTIFICA SRL | 2016-09-22 |
| 08033837190219 | BIOPSY DIGIT | I.M.S. INTERNAZIONALE MEDICO SCIENTIFICA SRL | 2016-09-22 |
| 08033837190202 | BIOPSY DIGIT | I.M.S. INTERNAZIONALE MEDICO SCIENTIFICA SRL | 2016-09-22 |
| 08033837190110 | GIOTTO IMAGE | I.M.S. INTERNAZIONALE MEDICO SCIENTIFICA SRL | 2016-09-22 |
| 08033837190103 | GIOTTO IMAGE | I.M.S. INTERNAZIONALE MEDICO SCIENTIFICA SRL | 2016-09-22 |
| 30382904094097 | BD PrecisionGlide | BECTON, DICKINSON AND COMPANY | 2016-09-16 |
| 30382904094080 | BD PrecisionGlide | BECTON, DICKINSON AND COMPANY | 2016-09-16 |
| 30382904094073 | BD PrecisionGlide | BECTON, DICKINSON AND COMPANY | 2016-09-16 |