Phased Array Transducer - - Pvf -375DT
by Toshiba America Medical Systems, In.C
510(k) K972771
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK972771 | Date11 Feb 1998 | 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- Withdrawn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
- ITX
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.1570
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The Phased Array Transducer PVF-375DT is a diagnostic ultrasound device classified as a phased array transducer under the Radiology product code (ITX). It employs phased array technology to generate focused ultrasound beams, enabling high-resolution imaging for applications such as cardiac, abdominal, and vascular assessments. This design allows for dynamic steering and focusing of sound waves, improving visualization of deep-seated structures and dynamic organs.
This transducer is supplied as a reusable component for use with Toshiba ultrasound systems, requiring proper cleaning and maintenance per manufacturer guidelines. It is intended for clinical settings where MRI safety is not a primary concern, as no specific MRI compatibility is noted. The device is authorized under FDA 510K clearance (K972771) and must be used in accordance with regulatory and institutional protocols to ensure patient safety and imaging accuracy.
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Questions
AI-generated answers, 19 Sep 2026
Is the PVF-375DT transducer designed for single-use or can it be reused in clinical settings?
The PVF-375DT is supplied as a reusable component for use with Toshiba ultrasound systems. It requires proper cleaning and maintenance as outlined in the manufacturer’s guidelines to ensure safe and accurate performance over multiple uses. Reuse is only permitted when following these protocols to maintain hygiene and functionality.
What types of imaging assessments is this phased array transducer primarily used for, and why?
The PVF-375DT is designed for high-resolution imaging of cardiac, abdominal, and vascular structures. Its phased array technology allows dynamic steering and focusing of ultrasound beams, which enhances visualization of deep-seated organs and dynamic tissues—critical for accurate diagnostic evaluations in these areas.
How should this transducer be stored, and are there any special handling requirements?
While the device data does not specify storage conditions explicitly, reusable ultrasound transducers like the PVF-375DT generally require clean, dry storage in a protective case to prevent damage. Proper cleaning and maintenance per manufacturer guidelines are essential before and after use to ensure longevity and sterility. Always follow institutional protocols for handling reusable medical devices.
Is this transducer compatible with MRI environments, and if not, why?
The PVF-375DT is not noted as MRI-compatible, meaning it should not be used in MRI environments unless explicitly verified by the manufacturer. Since MRI safety is a critical concern in those settings, clinicians should avoid using this transducer near MRI machines unless alternative, MRI-safe imaging tools are available.