# K982208: Irl Vasoscan (TM) Intravascular Ultrasound Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Jomed Imaging, Ltd.
- Decided: Aug 27, 1999 after 430 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) EndoSonics Visions Five-64 3.5F Solid State Intravascular Ultrasound Catheter: named in the summary without a submission number

## Indications for use
The indications for use of the IRL VasoScan™ intravascular ultrasound imaging system are for the visualization of the lumen and structure of the coronary arteries in patients affected by atherosclerosis who are suitable candidates for percutaneous transluminal coronary angioplasty (PTCA). The IRL VasoScan™ intravascular ultrasound catheter is for use only with the IRL VasoScan™ intravascular ultrasound imaging system.

Source page: https://510kreport.com/device/K982208
Methodology: https://510kreport.com/methodology