Data / Medical devices / Canada / Intelerad Medical Systems Incorporated
Intelerad Medical Systems Incorporated: FDA-registered device maker in MONTREAL Quebec, Canada, 1 510(k) clearance
Intelerad Medical Systems Incorporated is registered with the FDA (registration 9615916) in MONTREAL Quebec, Canada. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated April 2, 2020. 4 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9615916
- FEI number
- 3003768392
- Address
- 800, Boul. de Maisonneuve Est 14th floor, MONTREAL Quebec, Canada, H2L 4L8
- Owner or operator
- Intelerad Medical Systems Incorporated (9040757)
- Roles
- Manufacturer
- First device listed
- April 6, 2020
- Registered through
- 2026
- Brand names listed
- IntelePACS
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, Image Processing, Radiological | LLZ | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 2, 2020 | K192176 | IntelePACS | LLZ | Substantially Equivalent | Intelerad Medical Systems Incorporated | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| September 5, 2026 | 99899 | Class II | Ongoing | IntelePACS, InteleConnect Portal/Tech Portal Versions PACS-5-1-1-R102, PACS-5-2-1-R93, PACS-5-3-1-R83 through R128, PACS-5-4-1-R66 through R101, PACS-5-5-1-R50 through R89, PACS-5-6-1-R41 through R81, PACS-5-7-1-R21 thro | Following a Chromium-based web-browser, report and displayed images may not match. | accessdata.fda.gov |
| October 17, 2025 | 97868 | Class II | Ongoing | IntelePACS - InteleConnect / TechPortal | 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, whic | accessdata.fda.gov |
| February 5, 2025 | 96270 | Class II | Ongoing | IntelePACS (Image Fusion Module) - InteleViewer | 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 lea | accessdata.fda.gov |
| October 27, 2008 | 52761 | Not yet classified | Terminated | IntelePACS Picture Archiving Communications System InteleViewer Workstation Model #3.X.X. | Product software versions 3.5.2.P1 to 3.5.2.p56 inclusive and 3.6.1.P1 to 3.6.1.P82 inclusive were defective. | accessdata.fda.gov |
Compare with other makers
Updated October 15, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.