# K061560: Sonomark

- Pathway: 510(k) (Traditional)
- Applicant: Medical Products Manufacturing, Inc.
- Decided: Aug 18, 2006 after 74 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 K053463 (2006). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053463: Aim Accuracy in Marking System, Georgene Austria (2006) Summary page 1.

## Indications for use
The Sonomark accessory to linear diagnostic ultrasound transducers is indicated for diagnostic ultrasound procedures to mark anatomical features.

Source page: https://510kreport.com/device/K061560
Methodology: https://510kreport.com/methodology