# K053463: Aim Accuracy in Marking System

- Pathway: 510(k) (Traditional)
- Applicant: Georgene Austria
- Decided: Mar 7, 2006 after 84 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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) Sandel Medical Industries, LLC Skin Marker Class 1 exempt device: named in the summary without a submission number

## Most influential descendants
- K061560: Sonomark (2006), 0 descendants of its own

## Indications for use
Accuracy In Marking® is a marking device used in conjunction with a transducer during vascular mapping. The device allows the user to mark a vascular area immediately when it is identified during mapping process. The guide path underneath the transducer allows the user to identify the target vessel prior to marking. The product is supplied non-sterile and is intended for single use only.

Source page: https://510kreport.com/device/K053463
Methodology: https://510kreport.com/methodology