IQM Integral Quality Monitor
by Irt Systems
510(k) K162629
Active
Valid until
Not listed
FDA recalls
None foundTrust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK162629 | Date20 Oct 2016 | StatusActive |
| European Union | CE/MDR EUDAMED | Number— | Date— | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Full name
- IQM Integral Quality Monitor (also IQM)
- 510(k) Number
- FDA Product Code
- IYE
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.5050
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 18 Sep 2026
The IQM Integral Quality Monitor is a medical device classified as a Linear Accelerator accessory designed for real-time verification of radiation treatment delivery accuracy. It integrates quality assurance into the treatment workflow by continuously monitoring dose distribution during therapy, ensuring precision for complex treatment techniques, including small-field modalities.
The IQM is supplied as a reusable, non-sterile system intended for use in radiation oncology departments. It operates in the vicinity of linear accelerators and requires no additional sterility measures beyond standard clinical protocols. Authorized under FDA 510K and MDR, the device adheres to regulatory standards for radiation safety and quality assurance in medical imaging and radiotherapy. Installation and calibration follow manufacturer-provided guidelines to maintain accuracy and compliance.
Other devices from Irt Systems
Questions
AI-generated answers, 18 Sep 2026
What is the IQM Integral Quality Monitor primarily used for in a radiation oncology setting?
The IQM Integral Quality Monitor is designed for real-time verification of radiation treatment delivery accuracy during therapy. It integrates quality assurance into the workflow by continuously monitoring dose distribution, ensuring precision—especially for complex techniques like small-field modalities—used in radiation oncology.
Is the IQM Integral Quality Monitor single-use or reusable, and what sterility considerations apply?
The IQM is supplied as a reusable system and is non-sterile by design. No additional sterility measures beyond standard clinical protocols are required, as it operates in controlled radiation oncology environments where contamination risks are managed through routine cleaning and maintenance.
How is the IQM Integral Quality Monitor regulated, and what regulatory bodies have authorized its use?
The IQM has been authorized under both the FDA’s 510K pathway and the EU’s Medical Device Regulation (MDR). It adheres to regulatory standards for radiation safety and quality assurance in radiotherapy, with compliance verified through manufacturer-provided installation and calibration guidelines.
What types of linear accelerators is the IQM Integral Quality Monitor compatible with?
The IQM is classified as a Linear Accelerator accessory and is compatible with a broad range of systems, as indicated by its FDA product code (IYE) and associated registration numbers. Its design supports integration with standard linear accelerators used in radiation therapy, ensuring compatibility for dose verification across various modalities.
How should the IQM Integral Quality Monitor be stored when not in use?
While the device itself is non-sterile and reusable, it should be stored in a clean, dry environment following standard radiation oncology department protocols. The manufacturer’s guidelines for maintenance and calibration should be followed to preserve accuracy and ensure proper functionality before each use.