Model IW17.5A Intra Operative Transducer
by Kretztechnik AG 510(k)
Active
510(k) K904665
Overview
The Model IW17.5A Intra Operative Transducer is a Class II ultrasound device classified under the nomenclature code ITX, designed for real-time imaging during surgical procedures. It functions as an intraoperative imaging tool, enabling clinicians to visualize internal structures and guide interventions with precision. This transducer is specifically engineered for use in radiology settings, providing critical visual feedback to support surgical decision-making.
This device is supplied as a reusable medical instrument and has received FDA 510(k) clearance under K-number K904665, with a decision date of January 11, 1991. It is intended for use in MRI-unsafe environments, as ultrasound transducers are not MRI-compatible. Proper sterilization and maintenance protocols must be followed to ensure device integrity and patient safety. The Model IW17.5A is regulated under the classification name 'Transducer' and adheres to the applicable FDA standards for ultrasound imaging devices.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK904665 | Date11 Jan 1991 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
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
Other devices from Kretztechnik AG
Questions
What is the IW17.5A Intraoperative Transducer used for?
The IW17.5A Intraoperative Transducer is designed for real-time ultrasound imaging during surgical procedures. It allows clinicians to visualize internal structures and guide interventions with precision, particularly in radiology settings where immediate visual feedback is critical for decision-making.
Is the IW17.5A Intraoperative Transducer reusable or single-use?
The IW17.5A Intraoperative Transducer is supplied as a reusable medical instrument. Proper sterilization and maintenance protocols must be followed to ensure device integrity and patient safety, as outlined in the manufacturer’s guidelines.
Can the IW17.5A Intraoperative Transducer be used in MRI environments?
No, the IW17.5A Intraoperative Transducer is intended for use in MRI-unsafe environments. Ultrasound transducers like this one are not MRI-compatible, so caution must be exercised when used near MRI equipment to avoid interference or safety risks.
What regulatory clearance does the IW17.5A Intraoperative Transducer hold?
The IW17.5A Intraoperative Transducer has received FDA 510(k) clearance under K-number K904665, with a decision date of January 11, 1991. This clearance confirms it meets FDA standards for ultrasound imaging devices and is classified under the nomenclature code ITX.
How should the IW17.5A Intraoperative Transducer be stored?
While the provided data does not specify storage conditions, reusable medical devices like the IW17.5A Intraoperative Transducer should generally be stored in a clean, dry environment away from direct sunlight and extreme temperatures. Follow the manufacturer’s instructions for cleaning, disinfection, and storage to maintain device performance and ensure longevity.