# JAQ: System, Applicator, Radionuclide, Remote-Controlled

- Device class: 2; regulation: 21 CFR 892.5700; FDA's rule: 510(k) required
- FDA decisions: 208
- 510(k) review time 2021–2025: median 118 days (middle half 82–214)
- Recalls: 49 (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)
- 2016: 6
- 2017: 7
- 2018: 7
- 2019: 2
- 2020: 4
- 2022: 1
- 2023: 2
- 2024: 10
- 2025: 6
- 2026: 2

## Most-cited predicates
- K953946: Microselectron-HDR Version 2 (1996), cited by 28
- K983436: Gammamed Plus High Dose Rate Remote Afterloading System (1998), cited by 13
- K033371: Varian Intracavitary Brachytherapy Applicators (2003), cited by 8
- K011690: Mammosite Radiation Therapy System (RTS) Tray, Mammosite HDR Afterloader Accessories Tray (2002), cited by 7
- K945383: High Dose Rate Afterloader (1995), cited by 6
- K030558: Mammosite Radiation Therapy System (RTS) Tray, Mammosite HDR Afterloader Accessories Tray (2003), cited by 6
- K961601: H.a.M. Applicator (1996), cited by 6
- K952913: Applicators for Varian Varisource Remote High Soes Rate Afterloader (1995), cited by 6
- K030110: CT HDR Tandem/Ring Applicator with Rectal Retractor (2003), cited by 5
- K983341: Standard CT/MR Applicator Set,Ring CT/MR Applicator Set, Vaginal CT/MR Applicator Set, Fletcher Williamson Applicator SE (1999), cited by 5

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