Sontec II
by Sontec, Inc.
510(k) K844126
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SN | NumberK844126 | Date1 Jul 1985 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- IPF
- Device Class
- Class II
- Regulation
- 21 CFR Part 890.5850
- Advisory Committee
- Physical Medicine
- FDA Decision
- SN
Overview
AI-generated summary, 19 Sep 2026
The Sontec II is a Ultrasound Doppler Device (product code IPF), designed for non-invasive assessment of blood flow and vascular function. It employs Doppler ultrasound technology to detect and measure the velocity and direction of blood flow within vessels, aiding in the evaluation of circulatory conditions.
This device is intended for use in clinical settings by trained professionals, such as physical medicine specialists, for diagnostic purposes. Supplied as a reusable medical instrument, it requires proper maintenance and calibration to ensure accurate performance. The Sontec II holds FDA 510(k) clearance under the Traditional pathway, with a decision date of July 1, 1985, and is classified under the Physical Medicine advisory committee.
Questions
AI-generated answers, 19 Sep 2026
What clinical conditions or evaluations is the Sontec II Doppler device primarily used for assessing?
The Sontec II is designed for non-invasive assessment of blood flow and vascular function, helping evaluate circulatory conditions. It measures blood velocity and direction within vessels, which is particularly useful for diagnosing or monitoring peripheral vascular diseases, arterial occlusive disorders, or other conditions where blood flow dynamics are critical.
Is the Sontec II meant for single-use or can it be reused in a clinical setting?
The Sontec II is supplied as a reusable medical instrument. Since it requires proper maintenance and calibration to ensure accurate performance, it is intended for repeated use in clinical settings by trained professionals, such as physical medicine specialists.
How was the regulatory pathway for the Sontec II determined, and what does this mean for its use?
The Sontec II received FDA 510(k) clearance under the Traditional pathway, meaning it was determined to be substantially equivalent to a legally marketed device already on the market. This clearance was granted on July 1, 1985, and it falls under the Physical Medicine advisory committee’s purview, ensuring its compliance with established safety and performance standards for diagnostic ultrasound Doppler devices.
What kind of training or expertise is required to operate the Sontec II effectively?
The Sontec II is intended for use by trained professionals, specifically physical medicine specialists or other clinicians with expertise in vascular assessments. Its operation requires an understanding of Doppler ultrasound technology and circulatory evaluation to accurately interpret blood flow measurements and diagnose or monitor vascular conditions.