Touch Ultrasound
by Carestream Health, Inc. 2 variants
510(k) K150342
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK150342 | Date8 May 2015 | 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- Withdrawn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 Touch Ultrasound System is a portable ultrasound imaging device designed for radiologic examination. It employs advanced ultrasound technology to generate real-time visual images of internal body structures, aiding in diagnostic evaluations across various medical specialties. The system integrates tactile and configurable controls to enhance user interaction and workflow efficiency. Its primary function aligns with the classification of diagnostic ultrasound equipment, facilitating non-invasive assessments of organs, tissues, and vascular systems.
This device is intended for use in clinical settings such as hospitals, outpatient clinics, and emergency departments. Supplied as a reusable medical instrument, it requires proper cleaning and maintenance per manufacturer guidelines to ensure sterility and functionality. The system is MRI-unsafe and must be used in non-magnetic environments. Authorized for commercial distribution in the United States under FDA 510(k) clearance (K150342), it adheres to regulatory standards for diagnostic ultrasound devices. Storage and handling follow standard protocols for electronic medical imaging equipment.
Other devices from Carestream Health, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the Touch Ultrasound System used for?
The Touch Ultrasound System is designed for radiologic examinations, enabling real-time visualization of internal structures like organs, tissues, and blood vessels. Its advanced imaging capabilities assist clinicians in diagnosing conditions across specialties such as cardiology, obstetrics, and emergency care. The device’s tactile controls and portability make it ideal for dynamic clinical environments where quick, accurate assessments are critical.
How is the Touch Ultrasound System supplied and maintained?
The Touch Ultrasound System is supplied as a reusable medical instrument, meaning it is intended for repeated use across multiple patients. To ensure functionality and sterility, it must be cleaned and maintained according to the manufacturer’s guidelines. Proper disinfection and routine servicing are essential to prevent cross-contamination and preserve imaging quality, particularly in high-use settings like emergency departments or outpatient clinics.
Is the Touch Ultrasound System safe for use in all clinical environments?
No, the Touch Ultrasound System is not MRI-safe and must only be used in non-magnetic environments. This restriction is due to the electronic components and materials used in the device, which could be affected by magnetic fields. Clinicians should ensure the system is placed away from MRI machines or areas with strong magnetic interference to avoid potential malfunctions or safety hazards.
What storage and handling protocols should be followed for the Touch Ultrasound System?
The Touch Ultrasound System should be stored in a clean, dry environment protected from extreme temperatures, humidity, and physical damage. As electronic medical imaging equipment, it should be placed in a stable location away from direct sunlight or sources of electromagnetic interference. Regular calibration checks and adherence to manufacturer-recommended maintenance schedules will help sustain performance and extend the device’s operational lifespan.
Can the Touch Ultrasound System be used in emergency departments?
Yes, the Touch Ultrasound System is explicitly designed for use in emergency departments due to its portability and real-time imaging capabilities. Its compact and configurable design allows clinicians to perform rapid diagnostic assessments at the patient’s bedside, which is invaluable in time-sensitive scenarios. However, proper cleaning and sterility protocols must be followed to ensure safe reuse between patients.