# ITX: Transducer, Ultrasonic, Diagnostic

- Device class: 2; regulation: 21 CFR 892.1570; FDA's rule: 510(k) required
- FDA decisions: 415
- 510(k) review time 2021–2025: median 145 days (middle half 116–242)
- Recalls: 71 (10 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: 6
- 2018: 2
- 2019: 1
- 2020: 3
- 2021: 3
- 2022: 2
- 2023: 6
- 2024: 3
- 2025: 4
- 2026: 6

## Most-cited predicates
- K072786: Acuson S2000 Ultrasound System (2007), cited by 16
- K072164: DC-6 Diagnostic Ultrasound System (2007), cited by 12
- K982323: Olympus UM 2R/3R Ultrasonic Probes and Associated Ancillary Equipment, for Bronchial Use (1998), cited by 8
- K944610: Olympus Ultrasonic Probes (1995), cited by 6
- K982610: Olympus UM-2R/3R Ultrasonic Probes and Associated Ancillary Equipment (Urinary Tract) (1998), cited by 6
- K970513: General Purpose Tranducer Cover (1997), cited by 6
- K101757: Sonosite Nanomaxx Series Ultrasound System, Sonosite Maxx Series Ultrasound System (2010), cited by 5
- K963302: Tayman Medical, Inc. Stepping & Stabilizing System (1997), cited by 5
- K970049: BSC, Sonicath Ultra Imaging Catheter 3.2F/20MHZ (37410/456221 & BSC, Sonicath Ultra Imaging Catheter 2.9F/20MHZ/37411/ (1997), cited by 5
- K091941: DC-3/DC-3T Diagnostic Ultrasound System (2009), cited by 5

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