Intelerad Medical Systems Incorporated

Canada CA-MF-000011834 Last updated 22 Oct 2026

Catalogue3

Held under this manufacturer's EUDAMED registration, grouped by notified body; in force first, then by expiry.

Recalls this firm reported to the FDA. Device pages show the recalls that name the device or the 510(k)/PMA it was cleared under.

2026
- 5 Sep 2026 Z-0186-2027 Not yet classified Ongoing Following a Chromium-based web-browser, report and displayed images may not match.
2025
- 17 Oct 2025 Z-0723-2026 Class II Ongoing Software application that receives digital images and data to be communicated, processed, manipulated, enhanced, stored, displayed has a bug that could cause data loss in Relevant Clinical Info field when modifying studies through Case Editor in either Technologist Portal or Referring Physician Portal, which could result in loss of clinical information, which could impact clinical decision-making.
- 5 Feb 2025 Z-1208-2025 Class II Ongoing A software application that receives digital images and data from various sources has a bug in specific software versions that will calculate the Standard Uptake Value (SUV) incorrectly for PET/CT studies acquired on the days of Daylight Savings Time (DST); only on dates in which DST transition occurs; all other dates are unaffected. An incorrect SUV may lead to an incorrect diagnosis.

Intelerad is a leading medical imaging management company with decades of experience, specializing in scalable and flexible software solutions.

From the manufacturer's own website. Source