MAUI K3900 Ultrasound Imaging System — Available via Acertara
Available via Acertara
MAUI K3900 Ultrasound Imaging System
FDA-cleared K3900 with novel acquisition/reconstruction workflow; distribution and pre-order coordination through Acertara.
The MAUI K3900 is an FDA 510(k)-cleared (K230511) ultrasound imaging system designed for clinical use in adult and pediatric populations. The platform employs MAUI’s computed-echo reconstruction workflow, which differentiates it from conventional phased-array systems while maintaining standard ultrasound safety and portability.
Acertara led the most recent funding round and now supports U.S. distribution, demos, and pre-orders with an exclusive U.S. distributorship for hospitals outside of those that MAUI Imaging serves directly.
Compact, portable platform for flexible deployment
Modular architecture with ergonomic transducers
Broad compatibility with existing imaging workflows
Supported by 160+ patents in acquisition and reconstruction technologies
Learn more at MauiImaging.com
What the K3900 Is
The MAUI K3900 represents a new approach to diagnostic ultrasound. Its ping-based acquisition and reconstruction process differs from traditional beam-forming methods, enabling new workflows for clinicians without sacrificing familiarity.
Cleared Indications & Regulatory Clarity
FDA-cleared device: K3900 Ultrasound Imaging System (K230511)
Classification: 21 CFR 892.1560; Product Code IYO (pulsed-echo, ultrasonic)
Cleared Indications:
- Real-time diagnostic ultrasound imaging and fluid flow analysis
- Cleared for adult and pediatric patient populations in multiple anatomical areas
- Compatible with the approved transducers listed in the FDA record
Note:
Some capabilities discussed in the media/press are under active clinical study and are not part of the cleared indications.
Where MAUI & Acertara Add Value
As MAUI’s U.S. partner, Acertara provides end-to-end support through:
- Pre-order coordination and site readiness assessments
- Training logistics tailored to clinicians, biomedical engineers, and QA teams
- Commissioning and QA using tools like ATLAS for acceptance testing
- Post-market support with performance monitoring and feedback loops
Learn more about Acertara QA services or contact us to begin planning your implementation.
Clinical Workflows & Use Contexts
The K3900 is cleared for use as a diagnostic ultrasound system across multiple anatomical applications.
Hospitals and clinicians may explore its role within:
- Trauma evaluations where portability and speed are critical
- Interventional guidance workflows that require flexible ultrasound options
- ICU and OR environments where bedside imaging improves efficiency
At the heart of the K3900’s capability is computed echo tomography (CET) — a novel imaging paradigm in which the system emits unfocused acoustic “pings” and reconstructs the returning echoes using advanced algorithms. This approach bypasses conventional beam-forming limitations, enabling visualization through bone, gas, and other interfering structures with the same safety and portability of standard ultrasound.
Early peer-reviewed results demonstrate that CET can reveal intracranial, thoracic, and long-bone anatomy with fidelity and clarity uncommon in traditional imaging approaches.
FAQs
Is MAUI a replacement for CT or MRI?
No. The K3900 is an ultrasound system with a novel reconstruction process. See the FDA record for its cleared indications.
What is the K-number, and how do I verify clearance?
The K-number is K230511. The FDA device record lists the cleared indications and classifications.
What’s different about computed echo tomography (CET)?
CET uses a ping-and-reconstruct workflow rather than phased arrays, creating new acquisition possibilities.
Who handles U.S. demos and distribution?
Resource Library
| Resource | Link |
| MAUI Imaging $14M funding announcement | Learn More |
| MAUI K3900 Product Overview | Learn More |
| Clinical Workflow Solutions | Learn More |
| FDA 510(k) Clearance Record | Learn More |
| CET Baseline Peer-Reviewed Article | Learn More |
| AuntMinnie Industry Coverage | Learn More |
Compliance & Disclaimers
This page summarizes publicly available information and FDA clearance data for the MAUI K3900. Only cleared indications per K230511 are promoted. All other capabilities referenced in third-party sources are investigational and not promoted for sale.
Inquiry & Ordering
Interested in a demo or pre-order?
Complete the form, and our sales engineering team will respond with scheduling options and documentation.
1950 Lefthand Creek Lane, Longmont, CO 80501
+1 303.834.8413