# OGZ: Catheter, Intravascular, Plaque Morphology Evaluation

- Device class: 2; regulation: 21 CFR 870.1200; FDA's rule: 510(k) required
- FDA decisions: 9
- 510(k) review time 2021–2025: median 268 days (middle half 268–268)
- Recalls: 1 (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)
- 2008: 1
- 2010: 1
- 2013: 2
- 2014: 2
- 2017: 1
- 2019: 1
- 2025: 1

## Most-cited predicates
- K183599: Makoto Intravascular Imaging System, Dualpro IVUS + NIRS Imaging Catheter (2019), cited by 2
- K072932: Infraredix Nir Imaging System, Gen. 1.0, Model MC-5 (2008), cited by 1
- K141682: TVC Imaging System, TVC Insight Catheter (2014), cited by 1

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