# KGI: Densitometer, Bone

- Device class: 2; regulation: 21 CFR 892.1170; FDA's rule: 510(k) required
- FDA decisions: 148
- 510(k) review time 2021–2025: median 245 days (middle half 177–260)
- Recalls: 17 (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)
- 2012: 5
- 2013: 1
- 2014: 2
- 2016: 2
- 2018: 1
- 2019: 1
- 2022: 2
- 2023: 1
- 2025: 3
- 2026: 2

## Most-cited predicates
- K973104: Norland Model Pdexa Bone Densitometer (1998), cited by 6
- K011917: Advanced Hip Assessment Software (2001), cited by 5
- K023398: Hologic QDR X-Ray Bone Densitometer, Models 1000, 2000, 4500, Delphi, Discovery (2002), cited by 5
- K071570: GE Lunar Body Composition Software (2007), cited by 5
- K943505: Hologic QDR-3000 X-Ray Bone Densitometer (1995), cited by 5
- K001812: Pediatric Reference Data (2000), cited by 5
- K002113: Ctxa Hip; Ctxa; QCT Pro Ctxa Hip (2001), cited by 5
- K023554: Dual-Energy Vertebral Assessment View Software (2002), cited by 4
- K931996: Model Pdexa Bone Densitometer (1995), cited by 4
- K980569: Fracture Risk Assessment Capability for Norland X-Ray Bone Densitometers (1998), cited by 4

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