# IZH: System, X-Ray, Mammographic

- Device class: 2; regulation: 21 CFR 892.1710; FDA's rule: 510(k) required
- FDA decisions: 176
- 510(k) review time 2021–2025: median 226 days (middle half 226–226)
- Recalls: 12 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2008: 1
- 2010: 2
- 2011: 1
- 2012: 2
- 2013: 2
- 2015: 1
- 2016: 3
- 2019: 1
- 2020: 1
- 2021: 1

## Most-cited predicates
- K103512: Affirm Breast Biopsy Guidance System (2011), cited by 3
- K122836: Affirm Breast Biopsy Guidance System (2013), cited by 3
- K040125: Senographic Stereo (2004), cited by 3
- K861692: Fischer PPS/Mammotest Mammography System (1986), cited by 2
- K925725: Contour Mammography System, Model Number M-CTR (1993), cited by 2
- K030666: Multicare Platinum System and Accessories (2003), cited by 2
- K003795: Biolucent Mammography Cushion (2001), cited by 2
- K003945: Opdima (2001), cited by 2
- K941191: Real Time Stereotix (1995), cited by 2
- K013656: Planmed Sophie & Planmed Sophie Classic (2002), cited by 1

Source page: https://510kreport.com/product-code/IZH
Data by year (CSV): https://510kreport.com/product-code/IZH.csv