ProSound F75 Diagnostic Ultrasound System
by Hitachi Aloka Medical, Ltd. 2 variants
510(k) K140639
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK140639 | Date16 Apr 2014 | 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- Withdrawn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
- IYN
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.1550
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The ProSound F75 Diagnostic Ultrasound System is a medical imaging device classified as a diagnostic ultrasound system. It generates high-quality ultrasound images for diagnostic purposes, enabling real-time visualization of internal body structures such as organs, tissues, and blood flow. Designed for versatility, it supports a range of applications including obstetrics, cardiology, abdominal, and vascular imaging. Its advanced imaging capabilities allow clinicians to assess anatomical and pathological conditions with precision.
This system is intended for use in clinical settings such as hospitals, diagnostic centers, and private practices. It is supplied as a reusable, non-sterile device, requiring proper maintenance and calibration to ensure accurate performance. The ProSound F75 adheres to FDA 510(k) clearance under the Radiology advisory committee, with a clearance number of K140639. It operates within standard MRI safety guidelines for non-MRI environments and is not intended for use inside MRI scanners. Storage and handling follow manufacturer guidelines to preserve functionality and imaging quality.
Other devices from Hitachi Aloka Medical, Ltd.
Questions
AI-generated answers, 1 Oct 2026
What clinical applications is the ProSound F75 designed for?
The ProSound F75 Diagnostic Ultrasound System is engineered for a broad range of diagnostic imaging needs, including obstetrics (e.g., fetal monitoring), cardiology (heart structure and function), abdominal (organ assessment), and vascular studies (blood flow evaluation). Its advanced imaging technology ensures real-time visualization of internal structures, enabling precise assessment of anatomical and pathological conditions in clinical settings like hospitals and private practices.
Is the ProSound F75 a single-use or reusable device?
The ProSound F75 is a reusable diagnostic ultrasound system. As a non-sterile device, it requires regular maintenance, calibration, and cleaning per manufacturer guidelines to sustain optimal performance and imaging accuracy. Proper care extends its operational lifespan and ensures reliable diagnostic results.
What regulatory clearance does the ProSound F75 hold?
The ProSound F75 holds FDA 510(k) clearance under the Radiology advisory committee, with clearance number K140639. This classification confirms it is substantially equivalent to a predicate device and meets U.S. regulatory standards for diagnostic ultrasound systems. The system is not intended for MRI environments, adhering to standard MRI safety guidelines for non-MRI settings.
How should the ProSound F75 be stored and handled?
Storage and handling of the ProSound F75 follow manufacturer-provided guidelines to preserve functionality and imaging quality. The system should be stored in a clean, dry environment protected from extreme temperatures or physical damage. Regular maintenance, including calibration and cleaning, is essential to ensure consistent performance. Avoid exposure to moisture or contaminants, as these can compromise the device’s operational integrity.
Can the ProSound F75 be used inside an MRI scanner?
No, the ProSound F75 is not designed for use inside MRI scanners. It operates within standard MRI safety guidelines for non-MRI environments, meaning it complies with safety protocols for areas where MRI machines are not present. Always follow facility-specific protocols to ensure compatibility with the surrounding clinical equipment.