# K060947: Sonicath Ultra Imaging Catheter, 3.2F,20MHZ Models 37410/456221/C1020

- Pathway: 510(k) (Special)
- Applicant: Boston Scientific Corp
- Decided: Apr 19, 2006 after 13 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: 1 generation back to K970049 (1997). 1 ancestor in all.
11 later devices descend from it; 2 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970049: BSC, Sonicath Ultra Imaging Catheter 3.2F/20MHZ (37410/456221 & BSC, Sonicath Ultra Imaging Catheter 2.9F/20MHZ/37411/, Cardiovascular Imaging Systems, Inc. (1997) Summary page 1.

## Most influential descendants
- K092156: Cad 12, Colonoscopy Assist Device (2009), 7 descendants of its own
- K100624: Invendo C20 Colonoscopy System (2012), 6 descendants of its own
- K121582: Invendo C25 Colonoscopy System (2012), 5 descendants of its own
- K141286: Aer-O-Scope Colonoscope System (2014), 2 descendants of its own
- K073623: Atlantis 018 Peripheral Imaging Catheter (2008), 2 descendants of its own

## Indications for use
The Sonicath Ultra Tm 3.2F 20MHz Imaging Catheter is intended for ultrasound examination of peripheral intravascular pathology only. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal interventional procedures.

Source page: https://510kreport.com/device/K060947
Methodology: https://510kreport.com/methodology