510(k) K192176 ยท LLZ System, Image Processing, Radiological
IntelePACS
| Applicant | Intelerad Medical Systems Incorporated, Montreal, CA |
| Decision | Substantially Equivalent, Apr 2, 2020 |
| Received | Aug 12, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K192176
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 15, 2026 | INTELERAD MEDICAL SYSTEMS INCORPORATED 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, Open, Classified |
LLZ | None listed |
| Nov 26, 2025 | INTELERAD MEDICAL SYSTEMS INCORPORATED IntelePACS - InteleConnect / TechPortal Open, Classified |
LLZ | None listed |
| Feb 21, 2025 | INTELERAD MEDICAL SYSTEMS INCORPORATED IntelePACS (Image Fusion Module) - InteleViewer Open, Classified |
LLZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.