Regulatory Status
Devices supplied through Elastography Australia meet rigorous medical device safety and efficacy expectations, with regulatory clearances from major international bodies where applicable.
Clearances & Certifications
Regulatory Approvals
FDA 510(k) Cleared
ActiveUnited States
Devices supplied through Elastography Australia hold 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
K230XXX
2024
CE Marked
ActiveEuropean Union
Supplied devices carry 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
CE 0XXX
2024
TGA Approved
ActiveAustralia
The iLivTouch device family supplied through Elastography Australia is TGA approved and included on the Australian Register of Therapeutic Goods (ARTG), enabling lawful supply and clinical use in Australia.
Details
- Included on the Australian Register of Therapeutic Goods (ARTG)
- Available for supply to Australian healthcare providers
- Class IIa medical device
- Australian sponsor appointed
Reference
ARTG Listed
2026
Quality Assurance
Standards Compliance
The medical devices we supply are designed and manufactured by their OEMs 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.