# JAI: Couch, Radiation Therapy, Powered

- Device class: 2; regulation: 21 CFR 892.5770; FDA's rule: 510(k) required
- FDA decisions: 32
- 510(k) review time 2021–2025: median 340 days (middle half 340–340)
- 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)
- 2004: 4
- 2005: 1
- 2006: 3
- 2007: 2
- 2012: 4
- 2013: 1
- 2016: 1
- 2017: 1
- 2019: 1
- 2024: 1

## Most-cited predicates
- K910971: Z XT Radiation Therapy Treatment Table (1991), cited by 3
- K160518: LEONI ORION System (2016), cited by 3
- K983678: Elekta Oncology Systems Precise Treatment Table (1999), cited by 2
- K941927: The Nomos Crane (1995), cited by 2
- K031866: Med-Tec 6 Degree Axis Couch, Model MT-6DAC (2003), cited by 1
- K042146: Robocouch Patient Support System (2004), cited by 1
- K034054: Pro Series Couch Software, Model MT-PRO100 (2004), cited by 1
- K122413: Patient Positioning System (2012), cited by 1
- K060671: Kvue Igrt Treatment Table Top, RT-4551KV, Kvue Inserts and Accessories, Various (2006), cited by 1

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