IntelePACS— 510(k) K150707

Name: FDA 510(k) clearance K150707
Creator: U.S. Food and Drug Administration
Published: 2015-05-27

Substantially Equivalent

Intelerad Medical Systems Incorporated

FDA 510(k) clearance K150707 for IntelePACS, Substantially Equivalent on 2015-05-27. Applicant: Intelerad Medical Systems Incorporated. Device class: 2.

Clearance details

Applicant: Intelerad Medical Systems Incorporated
Product code: Code LLZ
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2015-03-19
Decision date: 2015-05-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Montreal, CA

Download summary PDF View on FDA.gov ↗

Recent devices under product code LLZ

view all

More clearances from Intelerad Medical Systems Incorporated

view all

K192176 — IntelePACS2020-04-02
K083520 — INTELEPACS, MODEL VERSION 3.X.X2009-06-23

Adverse events under product code LLZ

product code LLZ

Death: 13
Total: 13

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.