Browse hierarchy: [Radiology (RA)](/submissions/RA) → [Subpart B — Diagnostic Devices](/submissions/RA/subpart-b%E2%80%94diagnostic-devices) → [21 CFR 892.1710](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/892.1710) → IZH — System, X-Ray, Mammographic # IZH · System, X-Ray, Mammographic _Radiology · 21 CFR 892.1710 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZH ## Overview - **Product Code:** IZH - **Device Name:** System, X-Ray, Mammographic - **Regulation:** [21 CFR 892.1710](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/892.1710) - **Device Class:** 2 - **Review Panel:** [Radiology](/submissions/RA) - **3rd-party reviewable:** yes ## Identification A mammographic x-ray system is a device intended to be used to produce radiographs of the breast. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories. ## Classification Rationale Class II. ## Recent Cleared Devices (20 of 176) Showing 20 most recent of 176 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K203509](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZH/K203509.md) | SMART FINDER | Ims Giotto S.P.A. | Jul 14, 2021 | SESE | | [K202294](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZH/K202294.md) | Affirm Contrast Biopsy | Hologic, Inc. | Oct 5, 2020 | SESE | | [K191495](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZH/K191495.md) | Biopsy Positioner | Fujifilm Corporation | Jul 3, 2019 | SESE | | [K161575](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZH/K161575.md) | Affirm Lateral Arm Upright Biopsy Accessory | Hologic | Aug 10, 2016 | SESE | | [K161920](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZH/K161920.md) | Comfort Cover | Precision Dynamics Corporation | Jul 15, 2016 | SESE | | [K153486](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZH/K153486.md) | Affirm Prone Biopsy System | Hologic, Inc. | Apr 1, 2016 | SESE | | [K152038](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZH/K152038.md) | MammoGRIP | Women'S Imaging Solutions Enterprises, LLC | Dec 22, 2015 | SESE | | [K123414](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZH/K123414.md) | SPECBOARD JR. | Macbrud Corp., Medical Division | Jan 11, 2013 | SESE | | [K122836](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZH/K122836.md) | AFFIRM BREAST BIOPSY GUIDANCE SYSTEM | Lorad, A Hologic Co. | Jan 11, 2013 | SESE | | [K113607](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZH/K113607.md) | BIOPSY DIGIT S BIOPSY SL | Giotto USA, LLC | Aug 10, 2012 | SESE | | [K113284](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZH/K113284.md) | BIOPSY POSITIONER | Fuji Film Medical Systems | Mar 7, 2012 | SESE | | [K103512](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZH/K103512.md) | AFFIRM BREAST BIOPSY GUIDANCE SYSTEM | Hologic, Inc. | Jan 7, 2011 | SESE | | [K101373](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZH/K101373.md) | EMBRACE | Izi Medical Products, Inc. | Sep 15, 2010 | SESE | | [K100692](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZH/K100692.md) | DIGITAL SPOT MAMMOGRAPHY SYSTEM | Hologic, Inc. | Apr 6, 2010 | SESE | | [K073262](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZH/K073262.md) | BELLA | Beekley Corp. | Mar 26, 2008 | SESE | | [K071787](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZH/K071787.md) | BEMITT, MODEL 0001 | Dja Distributors, LLC | Oct 26, 2007 | SESE | | [K071542](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZH/K071542.md) | DIGITAL STEREOLOC II | Lorad, A Hologic Co. | Jul 5, 2007 | SESE | | [K070344](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZH/K070344.md) | LIV BREAST SELF EXAMINATION AID | Liv International USA, Inc. | Mar 8, 2007 | SESE | | [K062039](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZH/K062039.md) | BIOPSY DIGIT-AM | Giotto USA, LLC | Sep 11, 2006 | SESE | | [K050663](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZH/K050663.md) | TRAXYLOC-1 SYSTEM | Traxyz Medical, Inc. | Apr 8, 2005 | SESE | ## Top Applicants - Lorad Corp. — 11 clearances - Planmed OY — 11 clearances - Elscint, Inc. — 10 clearances - Fischer Imaging Corp. — 8 clearances - Bennett X-Ray Corp. — 7 clearances --- **Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZH](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZH) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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