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

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..

Clearance details

Applicant: Object Research Systems (Ors), Inc.
Product code: Code LLZ
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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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.