# K111043: Atlantis SR PRO2 Coronary Imaging Catheter, Icross Coronary Imaging Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corp
- Decided: Aug 4, 2011 after 111 days
- Product code: OBJ (Catheter, Ultrasound, Intravascular)
- Device class: 2
- Regulation: 21 CFR 870.1200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K050577 (2005). 2 ancestors in all.
9 later devices descend from it; 1 cites 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)
- K063312: Modification to Atlantis SR Pro 2 and SR Pro Coronary Imaging Catheters, Model 39014 and 38942, Boston Scientific Corp (2006) Summary page 1.

## Most influential descendants
- K123621: Opticross 40 MHZ Coronary Imaging Catheter (2013), 8 descendants of its own
- 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

## Indications for use
The iCrossTM and AtlantisrM SR Pro 2 Coronary Imaging Catheters are intended for ultrasound examination of coronary intravascular pathology only. Intravascular ultrasound imaging is indicated in patients who are candidates for translumninal coronary interventional procedures.

Source page: https://510kreport.com/device/K111043
Methodology: https://510kreport.com/methodology