# K073623: Atlantis 018 Peripheral Imaging Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corp
- Decided: Mar 13, 2008 after 78 days
- Product code: ITX (Transducer, Ultrasonic, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 892.1570
- 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 K970049 (1997). 4 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 7 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 2.
- K060947: Sonicath Ultra Imaging Catheter, 3.2F,20MHZ Models 37410/456221/C1020, Boston Scientific Corp (2006) Summary page 2.

## Most influential descendants
- K160514: OptiCross 18, 30 MHz Peripheral Imaging Catheter (2016), 1 descendant of its own
- K222568: OptiCross™ 18 Peripheral Imaging Catheter (2022), 0 descendants of its own

## Indications for use
The AtlantisTM 018 Peripheral Imaging Catheter is intended for intravascular ultrasound examination of peripheral vessels only. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal interventional procedures.

Source page: https://510kreport.com/device/K073623
Methodology: https://510kreport.com/methodology