# POK: Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer

- Device class: 2; regulation: 21 CFR 892.2060; FDA's rule: 510(k) required
- FDA decisions: 24
- 510(k) review time 2021–2025: median 154 days (middle half 118–176)
- Recalls: 0 (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)
- 2017: 1
- 2019: 1
- 2020: 2
- 2021: 2
- 2022: 1
- 2023: 1
- 2024: 6
- 2025: 5
- 2026: 5

## Most-cited predicates
- K201555: EchoGo Pro (2020), cited by 4
- DEN170022: QuantX (2017), cited by 4
- K200760: Rapid ASPECTS (2020), cited by 3
- K221564: Brainomix 360 e-ASPECTS (2023), cited by 2
- K242342: Fetal EchoScan (2024), cited by 2
- K212616: Koios DS (2021), cited by 2
- K190442: Koios DS for Breast (2019), cited by 2
- K251071: Fetal EchoScan (v1.1) (2025), cited by 1
- K242130: Koios DS (2024), cited by 1
- K202300: Optellum Virtual Nodule Clinic, Optellum software, Optellum platform (2021), cited by 1

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