VESSEL ANALYSIS AND AUTOPLAQUE FOR ORS VISUAL— 510(k) K122429

Name: FDA 510(k) clearance K122429
Creator: U.S. Food and Drug Administration
Published: 2012-11-28

Substantially Equivalent

Object Research Systems (Ors), Inc.

FDA 510(k) clearance K122429 for VESSEL ANALYSIS AND AUTOPLAQUE FOR ORS VISUAL, Substantially Equivalent on 2012-11-28. Applicant: Object Research Systems (Ors), Inc.. Device class: 2.

Clearance details

Applicant: Object Research Systems (Ors), Inc.
Product code: Code LLZ
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2012-08-09
Decision date: 2012-11-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Montreal, CA

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Recent devices under product code LLZ

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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.