7.5 MHz WP Transducer
510(k) K810748
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK810748 | Date19 Jun 1981 | 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- Withdrawn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, 1 Oct 2026
The 7.5 MHz WP Transducer is a diagnostic ultrasound probe designed for high-frequency imaging applications. It falls under the category of ultrasound transducers, specifically intended for detailed visualization of superficial structures due to its high-frequency output. This device converts electrical signals into ultrasound waves and vice versa, enabling real-time imaging for clinical assessment.
This transducer is supplied as a reusable medical device and is intended for use in radiology settings. It is not specified as sterile upon packaging but may require sterilization procedures depending on clinical protocols. The device is classified under product code ITX and holds an FDA 510(k) clearance (K810748) for substantial equivalence, granted in 1981. No additional regulatory markings or MRI safety classifications are provided in the available data.
Other devices from General Electric Co.
Questions
AI-generated answers, 1 Oct 2026
What is the 7.5 MHz WP Transducer used for?
The 7.5 MHz WP Transducer is designed for high-frequency ultrasound imaging, specifically to visualize superficial anatomical structures with high detail. Its 7.5 MHz frequency allows for enhanced resolution of shallow tissues, making it ideal for dermatological, musculoskeletal, and thyroid assessments where fine detail is critical.
Is the GE 7.5 MHz WP Transducer sterile when packaged?
The device is not supplied sterile upon packaging. It is classified as a reusable medical device, so clinical protocols must include appropriate sterilization procedures—such as autoclaving or chemical sterilization—before each use to ensure patient safety and device integrity.
How is the 7.5 MHz WP Transducer supplied, and what are its regulatory details?
The transducer is supplied as a reusable device, intended for use in radiology settings. It holds an FDA 510(k) clearance (K810748) under product code ITX, demonstrating substantial equivalence to a predicate device. The clearance was granted in 1981 via the Traditional 510(k) pathway, reviewed by the Radiology (RA) Advisory Committee.
Does this transducer require special handling or storage?
Since the 7.5 MHz WP Transducer is reusable, it must be cleaned, inspected, and sterilized between uses to prevent contamination and maintain performance. Storage should follow manufacturer guidelines to avoid damage to the probe’s delicate components, such as keeping it in a protective case away from extreme temperatures or physical stress.
Are there different models or sizes available for this transducer?
The provided data specifies only the 7.5 MHz WP Transducer model. No additional models or sizes are mentioned in the available documentation. For variations or alternatives, consult the manufacturer’s catalog or technical specifications.