Press Release

Sun Nuclear Announces Completion of Transition to CE Class IIb EU MDR Certification for Key Quality Management Solutions

SunCHECKยฎ Software, SRS MapCHECKยฎ and SunSCANโ„ข 3D Devices

Among 15+ Solutions Awarded New Certification

MELBOURNE, Fla.–(BUSINESS WIRE)–Sun Nuclear, a Mirion Medical company, announced today that its SunCHECKยฎ Quality Management software and key radiation therapy Quality Assurance (QA) devices have been awarded CE Class IIb certification under the European Medical Devices Regulation 2017/745 (EU MDR). The transition to EU MDR Class IIb recognizes the safety and performance of Sun Nuclear solutions and confirms compliance with stringent safety requirements.


Sun Nuclear solutions awarded Class IIb certification include:

  • The SunCHECKยฎ Platform, a comprehensive software application facilitating essential Patient and Machine QA workflows and centralized data management;
  • Patient-specific QA solutions, including the ArcCHECKยฎ, ArcCHECKยฎ-MR, MapCHECKยฎ 3 and SRS MapCHECKยฎ devices, for measurement of radiation dose distributions against planned doses;
  • Machine QA solutions, including the Daily QAโ„ข 3, Daily QAโ„ข 3-MR, IC PROFILERโ„ข, IC PROFILERโ„ข-MR devices, for routine QA of linear accelerators used in treatment delivery; and
  • Beam Dosimetry, Scanning and Commissioning solutions, including: the 1D SCANNERโ„ข and SunSCAN 3Dโ„ข water tanks; the PC Electrometerโ„ข for absolute dose calibration and EDGEโ„ข Detector for small-field beam modeling; and SNC125cโ„ข, SNC350pโ„ข and SNC600cโ„ข reference ion chambers.

โ€œFor 40 years, Sun Nuclear devices and software have helped radiation oncology and medical physics teams confidently adopt new technologies and techniques, enhance workflows, and improve patient care,โ€ said Luis Rivera, president of Sun Nuclear and executive vice president of Mirion Medical. โ€œThe transition to Class IIb EU MDR certification reinforces our commitment to safe, efficient, and effective cancer treatment globally, and further positions the company for ongoing success in Europe.โ€

The Sun Nuclear portfolio will be featured in booth #280 at ESTRO 2025, May 2-6, in Vienna, Austria. ESTRO 2025 is the annual congress for the European Society for Radiotherapy and Oncology and includes Europeโ€™s largest industry exhibition in radiation oncology.

About Sun Nuclear

Sun Nuclear is part of Mirion Medical, a group of healthcare-focused brands within Mirion, providing innovative solutions for Radiation Therapy and Diagnostic Imaging. More than 6,000 cancer centers worldwide rely on us for independent, integrated Quality Management. With a focus on ongoing support, Sun Nuclear aims to ease technology adoption, enhance workflows and improve outcomes โ€“ so that healthcare providers can achieve real results for Patient Safety. Learn more: sunnuclear.com.

Contacts

For investor inquiries:
Eric Linn, [email protected]

For media inquiries:
Erin Schesny, [email protected]

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