# K031894: Scantec Pad

- Pathway: 510(k) (Special)
- Applicant: Sonotech, Inc.
- Decided: Jul 18, 2003 after 29 days
- Product code: MUI (Media, Coupling, Ultrasound)
- 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.
10 later devices descend from it; 2 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K120882: Site Rite Prevue Ultrasound System and Pinpoint Needle Guide (2012), 8 descendants of its own
- K152554: Site-Rite 8 Ultrasound System, Site-Rite 8 Ultrasound System with Pinpoint GT Technology (2015), 6 descendants of its own
- K182281: Site~Rite 8 Ultrasound System with Cue Needle Tracking System and Pinpoint GT Needle Tech (2018), 4 descendants of its own
- K211193: BD Prevue II Peripheral Vascular Vascular Access System (2021), 2 descendants of its own
- K251673: X9 Ultrasound System (2025), 0 descendants of its own

## Indications for use
The biocompatible ScanTac Membrane or Pad will be used during medical diagnostic ultrasound imaging to couple sound waves between the patient's body and medical imaging electronics by being affixed to the active element of the transducer. The ScanTac Pad is biocompatible, sterile, and, being solid, leaves no residue. It will be used for transcutaneous ultrasound imaging over surgical wounds, during transcutaneous biopsy and to enhance acoustic coupling to difficult geometries. The Pad is placed onto the patient, and is sufficiently adherent to remain in place during the scan due to the adhesive nature of the hydrogel. The exposed side of the hydrogel pad will be rendered lubricous with an application of ultrasound coupling sterile fluid, including ScanLube™, water or saline.

Source page: https://510kreport.com/device/K031894
Methodology: https://510kreport.com/methodology