# IXI: Block, Beam-Shaping, Radiation Therapy

- Device class: 2; regulation: 21 CFR 892.5710; FDA's rule: 510(k) required
- FDA decisions: 51
- 510(k) review time 2021–2025: median 78 days (middle half 71–85)
- Recalls: 5 (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)
- 2003: 2
- 2004: 2
- 2006: 3
- 2007: 2
- 2009: 3
- 2011: 2
- 2012: 1
- 2013: 3
- 2022: 2
- 2026: 1

## Most-cited predicates
- K001163: DMLC IV-Ergo (2000), cited by 5
- K040804: .Decimal Tissue Compensator/Intensity Modulator (2004), cited by 4
- K071078: .Decimal Range Compensator (2007), cited by 3
- K040553: Modification to Acculeaf (2004), cited by 3
- K071077: .Decimal Aperture (2007), cited by 2
- K000349: Motorized Micro Multileaf Collimator (2000), cited by 2
- K010172: Lead Blocks (2001), cited by 2
- K000137: Enhanced Compensating Filter (2000), cited by 2
- K990491: Angio-CT Miyabi (1999), cited by 2
- K953894: Siemens Multileaf Collimator (1995), cited by 2

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