IZH — System, X-Ray, Mammographic Class II
FDA product code IZH covers "System, X-Ray, Mammographic", a Class II medical device regulated under 21 CFR 892.1710. Submissions are reviewed by the Radiology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- IZH
- Device Class
- Class II
- Regulation Number
- 892.1710
- Submission Type
- Review Panel
- RA
- Medical Specialty
- Radiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K203509 | ims giotto | SMART FINDER | July 14, 2021 |
| K202294 | hologic | Affirm Contrast Biopsy | October 5, 2020 |
| K191495 | fujifilm corporation | Biopsy Positioner | July 3, 2019 |
| K161575 | hologic | Affirm Lateral Arm Upright Biopsy Accessory | August 10, 2016 |
| K161920 | precision dynamics corporation | Comfort Cover | July 15, 2016 |
| K153486 | hologic | Affirm Prone Biopsy System | April 1, 2016 |
| K152038 | women imaging solutions enterprises | MammoGRIP | December 22, 2015 |
| K123414 | macbrud corp., medical division | SPECBOARD JR. | January 11, 2013 |
| K122836 | lorad, a hologic | AFFIRM BREAST BIOPSY GUIDANCE SYSTEM | January 11, 2013 |
| K113607 | giotto usa | BIOPSY DIGIT S BIOPSY SL | August 10, 2012 |
| K113284 | fuji film medical systems | BIOPSY POSITIONER | March 7, 2012 |
| K103512 | hologic | AFFIRM BREAST BIOPSY GUIDANCE SYSTEM | January 7, 2011 |
| K101373 | izi medical products | EMBRACE | September 15, 2010 |
| K100692 | hologic | DIGITAL SPOT MAMMOGRAPHY SYSTEM | April 6, 2010 |
| K073262 | beekley | BELLA | March 26, 2008 |
| K071787 | dja distributors | BEMITT, MODEL 0001 | October 26, 2007 |
| K071542 | lorad, a hologic | DIGITAL STEREOLOC II | July 5, 2007 |
| K070344 | liv international usa | LIV BREAST SELF EXAMINATION AID | March 8, 2007 |
| K062039 | giotto usa | BIOPSY DIGIT-AM | September 11, 2006 |
| K050663 | traxyz medical | TRAXYLOC-1 SYSTEM | April 8, 2005 |