Ultrasound Probe Quality Is Non-Negotiable

Ultrasound is safe, non-ionizing, and ubiquitous, but its diagnostic value depends on probe performance.

• Subtle acoustic degradation can cause misdiagnosis or failed procedures.
• Inadequate testing of repaired probes can void compliance.
• Uncalibrated hydrophones can produce invalid testing results.
• Many service providers rely on pass/fail visual checks or outdated methodologies.

Acertara delivers FDA-grade performance data for ultrasound probes backed by lab-grade calibration, validated protocols, and international standards.

Ultrasound Probe Testing

Your probe isn’t safe just because it powers on.

We deliver quantitative acoustic performance data that determines whether an ultrasound probe still meets original manufacturer specifications, which is critical for both repaired and new devices.

What We Test

• Acoustic output (pressure, intensity, power)
• Image quality and uniformity
• Electrical leakage and cable integrity
• Thermal safety performance

 Why It Matters

• Confirms return-to-OEM performance post-repair
• Mitigates risk of device failure in patient care
• Supports compliance with FDA, IEC 60601, and OEM specs
• Full testing report suitable for HTM records or OEM documentation.

Ultrasound Probe Repair Services

We repair a broad range of diagnostic ultrasound probes, including:

• Linear, convex, and phased array probes
• Intracavitary and TEE (transesophageal) probes
• 2D, 3D, and 4D imaging transducers
• Biopsy-compatible and specialty probes

What sets Acertara apart:

• Return-to-OEM-spec validation using quantitative acoustic measurements—not guesswork
• Root-cause failure analysis before repair begins, ensuring long-term reliability
• Post-repair performance testing to FDA and IEC standards
• Support for QA documentation and regulatory audit readiness
• Transparent communication throughout the repair process, including failure mode reporting

FDA 510(k) Submission Consulting

Ultrasound probes are often Class II medical devices that require extensive documentation and validated testing to secure FDA clearance. We’ve helped secure over 200 successful 510(k) submissions.

• Predicate device research & substantial equivalence
• Labeling, risk management, and usability documentation
• Acoustic testing design & FDA audit response support
• Real-time guidance throughout submission lifecycle

Hydrophone Calibration & Acoustic Measurement

Your testing is only as good as your calibration. Acertara is one of the few U.S. labs qualified to perform IEC 62127-1 compliant hydrophone calibration for ultrasound probe testing applications.

• Free-field acoustic pressure calibration
• Intensity, power, and beam profile measurement
• Traceability to national measurement standards (NIST)
• Data suitable for FDA and international submissions

Contract Engineering & R&D

From napkin sketch to production-ready transducer, we help clients build ultrasound probes that meet acoustic, electrical, and regulatory requirements — without guesswork.

• Custom transducer design & modeling
• Acoustic characterization of new materials
• PCB integration & system architecture
• DFM optimization for probe production

Consulting for Testing Programs & Quality Systems

Need help building a defensible in-house testing program? We help HTM teams and ISOs build probe QA workflows with the same rigor we use in our accredited lab.

• SOP design for probe acceptance testing
• Training on acoustic performance metrics
• Compliance gap analysis for FDA and IEC
• Calibration audit support