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Systems

Premium Sound System› MRItv™ 4K Pro›
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Quality & certifications.

Our quality management system is certified to ISO 13485:2016. The certificate, our quality policy and the tests behind our products are here.

ISO 13485Certified quality system
510(k)FDA-cleared audio system
IEC 60601-1Medical electrical equipment
29 dBHearing protection, ISO 17025 lab

Documents to download.

For supplier onboarding and purchasing. Something else you need? Ask us.

  • ISO 13485:2016 certificateMRIaudio, Inc. · 2026View
  • Quality policyA-530-001-A · PDFDownload
  • Purchase order clausesA-740-001-B · PDFDownload

Tested and certified

  • IEC 60601-1, medical electrical equipment
  • Hearing protection: in-ear headset tips
  • Hearing protection: over-ear headphones
  • Hearing protective device testNumber Q4261A
  • Intracutaneous (intradermal) reactivity
  • Cytotoxicity, MEM elution
  • Maximization test for delayed-type hypersensitivity
  • Magnetic field attraction: 3G transducer and mountPremium system, tested
  • FDA 510(k) clearance

Ready when you are.

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