# JAD: System, Therapeutic, X-Ray

- Device class: 2; regulation: 21 CFR 892.5900; FDA's rule: 510(k) required
- FDA decisions: 53
- 510(k) review time 2021–2025: median 194 days (middle half 103–262)
- Recalls: 10 (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)
- 2013: 5
- 2014: 1
- 2015: 1
- 2016: 2
- 2017: 1
- 2018: 1
- 2019: 2
- 2022: 1
- 2023: 1
- 2025: 2

## Most-cited predicates
- K992577: Photon Radiosurgery System (PRS) (1999), cited by 4
- K150037: Sensus Healthcare Superficial X-ray Radiation Therapy System with Ultrasonic Imaging Capabilities (2015), cited by 3
- K121653: Intrabeam System with Intrabeam Spherical Applicators (2012), cited by 3
- K122951: Xoft Axxent Electronic Brachytherapy System Model 110 (2013), cited by 2
- K090584: Intrabeam System with Balloon Applicator and CBG Sets (2009), cited by 2
- K980526: Photon Radiosurgery System PRS400 (1998), cited by 2
- K063456: SRT100 Superficial Radiation Therapy System (2007), cited by 2
- K051055: Intrabeam System (2005), cited by 2
- K050843: Axxent Electronic Brachytherapy System (2005), cited by 2
- K971074: Therapax SXT 150 (1997), cited by 2

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