IntelePACS— 510(k) K192176
Substantially EquivalentIntelerad Medical Systems Incorporated
FDA 510(k) clearance K192176 for IntelePACS, Substantially Equivalent on 2020-04-02. Applicant: Intelerad Medical Systems Incorporated. Device class: 2.
Clearance details
- Applicant
- Intelerad Medical Systems Incorporated
- Product code
- Product code LLZ
- Device class
- Class 2
- Regulation
- 21 CFR 892.2050
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Montreal, CA
Recent devices under product code LLZ
view allMore clearances from Intelerad Medical Systems Incorporated
view allAdverse events under product code LLZ
product code LLZ- Death
- 13
- Total
- 13
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K192176
K-number listed on FDA's recall record- Z-0186-2027 — 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 through R61, PACS-5-8-1-R2 through R42, PACS-5-9-1-R8 through R19; System, Image Processing, Radiological
- Z-0723-2026 — IntelePACS - InteleConnect / TechPortal
- Z-1208-2025 — IntelePACS (Image Fusion Module) - InteleViewer
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K192176.
Data sourced from openFDA. This site is unofficial and independent of the FDA.