HeartFocus (V.1.1.1)
by Deski 510(k)
Active
510(k) K242807
Overview
HeartFocus (V.1.1.1) is an Image Acquisition and/or Optimization Guided by Artificial Intelligence device, designed to enhance ultrasound imaging quality. Classified as a Class II medical device under FDA regulations (892.2100), it leverages AI algorithms to assist radiologists in capturing diagnostic-grade ultrasound images. The system is tailored for use in radiology settings, where precise imaging is critical for cardiac and vascular assessments. Its primary function is to improve image clarity and consistency, reducing operator variability in ultrasound procedures.
HeartFocus (V.1.1.1) is supplied as software integrated with ultrasound systems and is intended for use by trained medical professionals in radiology departments. The device operates as a non-sterile, reusable digital tool, requiring no special storage conditions beyond standard IT infrastructure. It is MRI-safe as it does not contain ferromagnetic components or emit electromagnetic interference. Authorized under FDA 510(k) clearance (K242807) with a Traditional review pathway, HeartFocus adheres to regulatory standards for AI-assisted imaging devices in radiology.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK242807 | Date4 Apr 2025 | 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- Withdrawn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
- QJU
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.2100
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Questions
What is HeartFocus (V.1.1.1) used for?
HeartFocus (V.1.1.1) is an AI-powered software tool designed to improve ultrasound imaging quality in radiology departments. It assists radiologists by optimizing image acquisition and consistency, particularly for cardiac and vascular evaluations, where precise imaging is critical. The device helps minimize variability in ultrasound procedures, ensuring diagnostic-grade images are captured more reliably.
How is HeartFocus (V.1.1.1) supplied and used?
HeartFocus (V.1.1.1) is supplied as software integrated with existing ultrasound systems. It is intended for use by trained medical professionals in radiology departments. The system operates as a digital tool, requiring no additional hardware beyond standard IT infrastructure. It is non-sterile and reusable, meaning it can be utilized repeatedly across multiple procedures without replacement.
Is HeartFocus (V.1.1.1) sterile or single-use?
HeartFocus (V.1.1.1) is a non-sterile, reusable digital tool. Since it is software-based and does not come into direct contact with patients or sterile environments, sterility is not a requirement. Its reusable nature aligns with standard IT practices for medical imaging software, ensuring cost-effective and efficient use in clinical settings.
What storage requirements does HeartFocus (V.1.1.1) have?
HeartFocus (V.1.1.1) does not require special storage conditions beyond those needed for standard IT infrastructure. As a software-based solution, it must be stored on compatible hardware (e.g., ultrasound systems or connected devices) with proper environmental controls to prevent data corruption or system failures. No additional sterilization or containment measures are necessary.
Is HeartFocus (V.1.1.1) safe for use in MRI environments?
Yes, HeartFocus (V.1.1.1) is designed as MRI-safe. The device contains no ferromagnetic components and does not emit electromagnetic interference, making it suitable for use in MRI environments without risk of interference or safety hazards. This ensures compatibility with multi-modality radiology departments where both ultrasound and MRI procedures may be performed.