Tetrad (Tc-EC7-Acp +3 more) - -L7-
by Tetrad Corp.
510(k) K013849
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK013849 | Date3 Dec 2001 | 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- Withdrawn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
- Models / Variants
- -L7-
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.1570
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Tetrad Model TC-EC7-ACP, TC-EC7-L5, TC-EC7-L7, and TC-EC7-V4-ACP Transducers are ultrasound transducers designed for diagnostic imaging. These devices convert electrical signals into acoustic waves and vice versa, enabling visualization of internal body structures via ultrasound systems. They are categorized under the product code ITX, indicating their role in radiologic imaging equipment. The transducers are intended for use with ultrasound machines to facilitate diagnostic procedures in medical settings.
These transducers are supplied as reusable medical devices and are intended for use in clinical environments where ultrasound imaging is performed. The FDA has classified them as substantially equivalent under 510(k) clearance (K013849), with a review by the Radiology Advisory Committee. No specific sterility or MRI safety information is provided in the data, but they are regulated under traditional 510(k) pathways. The devices are part of a legacy product line and are not described as single-use or disposable.
Other devices from Tetrad Corp.
Questions
AI-generated answers, 1 Oct 2026
What are the Tetrad TC-EC7 transducers used for?
The Tetrad TC-EC7 transducers (models TC-EC7-ACP, -L5-, -L7-, and -V4-ACP) are designed specifically for diagnostic ultrasound imaging. They convert electrical signals into acoustic waves and vice versa, allowing clinicians to visualize internal body structures using ultrasound machines. These transducers are part of a legacy product line and are intended for use in clinical environments where ultrasound procedures are performed.
Are the Tetrad TC-EC7 transducers single-use or reusable?
The Tetrad TC-EC7 transducers are supplied as reusable medical devices. Unlike single-use or disposable transducers, these are intended for repeated use in clinical settings, provided they are properly cleaned, maintained, and sterilized between procedures. The manufacturer does not specify sterility requirements, so adherence to standard clinical decontamination protocols is essential.
What models are included in the Tetrad TC-EC7 series?
The Tetrad TC-EC7 series includes four distinct models: TC-EC7-ACP, TC-EC7-L5, TC-EC7-L7, and TC-EC7-V4-ACP. Each model is designed for ultrasound imaging but may differ in technical specifications such as frequency range, probe shape, or application focus. The exact differences between these models are not detailed in the provided data, but they are all categorized under the product code ITX for radiologic imaging equipment.
How were these transducers regulated by the FDA?
The Tetrad TC-EC7 transducers were reviewed and cleared by the FDA under a 510(k) submission (K013849) as substantially equivalent to a predicate device. The review was conducted by the Radiology Advisory Committee (RA) and followed a traditional 510(k) pathway. This clearance indicates that the FDA determined the device to be as safe and effective as legally marketed alternatives, though no specific sterility or MRI safety information is provided.
What is the product code classification for these transducers?
The Tetrad TC-EC7 transducers fall under the FDA product code ITX, which categorizes them as radiologic imaging equipment. This classification aligns with their intended use in ultrasound systems for diagnostic imaging purposes. The ITX code helps regulatory bodies and healthcare providers identify the device’s role within the broader context of medical imaging technology.