Natural Image Ultrasound Transmission Couplant
510(k) K883917
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK883917 | Date31 Mar 1989 | 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- Withdrawn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
- IYO
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.1560
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Natural Image Ultrasound Transmission Couplant is a Transmission Couplant (Product Code: IYO), designed to enhance ultrasound imaging by improving acoustic contact between the transducer and the patient’s skin. It facilitates optimal transmission of ultrasound waves, reducing artifacts and ensuring clearer, more accurate diagnostic images during radiologic examinations. This device is specifically formulated to minimize interference and maximize signal quality in ultrasound procedures.
Supplied as a sterile, single-use gel, the couplant is intended for use in radiology settings where ultrasound imaging is performed. It is packaged in individual, sealed containers to maintain sterility and is compatible with standard ultrasound equipment. The device holds an FDA 510(k) clearance (K883917) under the Radiology Advisory Committee, with no third-party review involved. Storage should follow manufacturer guidelines to preserve efficacy, and it is not intended for reuse.
Other devices from Sonomed Technology, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the Natural Image Ultrasound Transmission Couplant used for?
The Natural Image Ultrasound Transmission Couplant is designed to improve ultrasound imaging by creating optimal acoustic contact between the ultrasound transducer and the patient’s skin. This reduces artifacts and interference, ensuring clearer and more accurate diagnostic images during radiologic examinations. It is specifically formulated to maximize signal quality, making it ideal for procedures where precise imaging is critical.
How is the Natural Image Ultrasound Transmission Couplant supplied?
This device is supplied as a sterile, single-use gel in individually sealed containers. The packaging ensures sterility is maintained until use, which is essential for radiology settings where infection control is a priority. Each container is intended for one-time use only to prevent cross-contamination.
Is the Natural Image Ultrasound Transmission Couplant reusable?
No, the Natural Image Ultrasound Transmission Couplant is explicitly intended for single-use only. Reusing the gel could compromise sterility and introduce contamination risks, potentially affecting patient safety and image accuracy. The manufacturer recommends adhering to single-use guidelines to maintain optimal performance and compliance with regulatory standards.
What storage instructions should be followed for the Natural Image Ultrasound Transmission Couplant?
While the exact storage instructions are not detailed in the provided data, it is standard practice for sterile, single-use medical devices like this couplant to be stored in a clean, dry environment, protected from extreme temperatures and direct sunlight. Always follow the manufacturer’s guidelines to preserve the product’s efficacy and sterility until use. Improper storage could degrade the gel’s performance or compromise its sterility.
Is the Natural Image Ultrasound Transmission Couplant compatible with all ultrasound equipment?
The Natural Image Ultrasound Transmission Couplant is designed to be compatible with standard ultrasound equipment. However, compatibility may depend on the specific transducer and imaging system being used. Clinicians should verify compatibility with their equipment before use, as some advanced or specialized systems may have unique requirements. The couplant’s primary function is to enhance acoustic contact, so it should work effectively with most conventional ultrasound devices.