Scantac Membrane or Scantac Strip

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K013170 ↗

FDA Product Code

ITX

Device Class

Class II

Regulation

21 CFR Part 892.1570

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Sonogel

  Class II

  FDA 510(k) K953468 Active Cleared 17 Oct 1995

• Sonoscan

  Class II

  FDA 510(k) K961692 Active Cleared 22 Aug 1996

• Ultramix

  Class II

  FDA 510(k) K962093 Active Cleared 23 Dec 1996

• Endo-Glide

  Class II

  FDA 510(k) K013701 Active Cleared 4 Feb 2002

• Oasis

  Class II

  FDA 510(k) K964658 Active Cleared 14 Feb 1997

• Vivosonic

  Class II

  FDA 510(k) K984562 Active Cleared 8 Jun 1999

See all devices from Sonotech, Inc. →

• What is the Scantac Membrane or Scantac Strip used for?

  The Scantac Membrane or Scantac Strip is used as a solid, biocompatible hydrogel-based ultrasound coupling device that substitutes for traditional liquid ultrasound coupling gels in radiology procedures.

• How is the Scantac Membrane or Scantac Strip supplied?

  The device is supplied as a solid hydrogel-based membrane or strip, designed to replace liquid ultrasound gel during imaging procedures.

• Is the Scantac Membrane or Scantac Strip sterile and intended for single use?

  The device data does not specify sterility or single-use status; therefore, no claim about sterility or reuse can be made based on the provided information.

• What regulatory pathway was used for the Scantac Membrane or Scantac Strip?

  The device was cleared by the FDA under the 510(k) pathway, specifically under submission K013170, and was found substantially equivalent to a predicate device.