# KPS: System, Tomography, Computed, Emission

- Device class: 2; regulation: 21 CFR 892.1200; FDA's rule: 510(k) required
- FDA decisions: 473
- 510(k) review time 2021–2025: median 60 days (middle half 32–101)
- Recalls: 267 (17 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2017: 11
- 2018: 13
- 2019: 3
- 2020: 12
- 2021: 15
- 2022: 5
- 2023: 12
- 2024: 11
- 2025: 12
- 2026: 6

## Most-cited predicates
- K041022: Neuroq - Pet DP (2004), cited by 7
- K982855: Digirad 2020TC Spect Imaging System (1998), cited by 7
- K052640: Gemini Raptor (2005), cited by 6
- K002715: Ecat Pet Scanner (2000), cited by 6
- K991841: Hawkeye Option for Dual-Head Variable Angle Gamma Camera (1999), cited by 6
- K021656: Hermes Hdaq Acquisition Station and Hermes Workstation, Ver. 3.4 (2002), cited by 6
- K962797: Ecat Exact & Ecat Exact HR+ (1996), cited by 5
- K963983: E. Cam Profile Attenuation Correction (1997), cited by 5
- K992731: E.Cam Computer (1999), cited by 5
- K172143: uMI 780 PET/CT System (2018), cited by 5

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