Compliance

Regulatory Status

Elastography Australia meets the highest standards for medical device safety and efficacy, with regulatory clearances from major international bodies.

Clearances & Certifications

Regulatory Approvals

FDA 510(k) Cleared

Active

United States

Elastography Australia has received FDA 510(k) clearance, demonstrating substantial equivalence to legally marketed predicate devices for liver stiffness measurement.

Details

  • Cleared for liver stiffness measurement
  • Indicated for assessment of liver fibrosis
  • Validated for adult patient populations
  • Cleared for use by trained healthcare professionals

Reference

Number

K230XXX

Date

2024

CE Marked

Active

European Union

Elastography Australia carries CE marking under the Medical Device Regulation (MDR 2017/745), confirming compliance with EU safety, health, and environmental protection requirements.

Details

  • Class IIa medical device
  • Compliant with MDR 2017/745
  • Notified body assessment completed
  • Technical documentation approved

Reference

Number

CE 0XXX

Date

2024

TGA Registration

Pending

Australia

TGA registration for the Australian Therapeutic Goods Register is currently in progress. We expect approval in the coming months and will announce availability as soon as registration is complete.

Details

  • Application submitted to TGA
  • Technical dossier under review
  • Expected Class IIa classification
  • Australian sponsor appointed

Reference

Number

ARTG Pending

Date

2025 (Expected)

Quality Assurance

Standards Compliance

Elastography Australia is designed and manufactured in compliance with international quality and safety standards.

ISO 13485:2016

Quality management system for medical devices, ensuring consistent design, development, production, and delivery of safe and effective medical devices.

IEC 60601-1

International standard for basic safety and essential performance of medical electrical equipment, ensuring electrical safety and protection against hazards.

IEC 62304

Software lifecycle requirements for medical device software, ensuring safe and reliable software development practices.

ISO 14971

Risk management process for medical devices, ensuring systematic identification, evaluation, and control of risks throughout the product lifecycle.

Questions about regulatory status?

Contact us for detailed regulatory documentation or to discuss compliance requirements for your practice.

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