# K123621: Opticross 40 MHZ Coronary Imaging Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corp
- Decided: Apr 15, 2013 after 143 days
- Product code: OBJ (Catheter, Ultrasound, Intravascular)
- Device class: 2
- Regulation: 21 CFR 870.1200
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K050577 (2005). 3 ancestors in all.
8 later devices descend from it; 3 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111043: Atlantis SR PRO2 Coronary Imaging Catheter, Icross Coronary Imaging Catheter, Boston Scientific Corp (2011) Summary page 3.

## Most influential descendants
- K153617: OptiCross 6, 40 MHz Coronary Imaging Catheter (US Distribution), OptiCross 6, 40 MHz Coronary Imaging Catheter (EU Distribution), OptiCross 6, 40 MHz Coronary Imaging Catheter (Intercontinental Distribution) (2016), 5 descendants of its own
- K173820: OptiCross 6 HD, 60 MHz Coronary Imaging Catheter (Paper DFU), OptiCross 6 HD, 60 MHz Coronary Imaging Catheter (e-DFU) (2018), 3 descendants of its own
- K173284: OptiCross HD, 60 MHz Coronary Imaging Catheter (Paper DFU); OptiCross HD, 60 MHz Coronary Imaging Catheter (e-DFU) (2017), 3 descendants of its own
- K213593: OptiCross, OptiCross HD, OptiCross 6, OptiCross 6 HD (2022), 2 descendants of its own
- K230453: OptiCrossTM HD Coronary Imaging Catheter, OptiCrossTM 6 HD Coronary Imaging Catheter (2023), 1 descendant of its own

## Recalls of this device
- Mar 5, 2024 · Class II · Z-1396-2024: Certain batches of Opticross 40MHz Coronary Imaging Catheters manufactured using an incorrect voltage setting, which may have resulted in decreased image brightness.

## Indications for use
This catheter is intended for ultrasound examination of coronary intravascular pathology only. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal coronary interventional procedures.

Source page: https://510kreport.com/device/K123621
Methodology: https://510kreport.com/methodology