Curve Image 2.0 PACS— 510(k) K173101

Name: FDA 510(k) clearance K173101
Creator: U.S. Food and Drug Administration
Published: 2017-10-18

Substantially Equivalent

Curve Dental, Ltd.

FDA 510(k) clearance K173101 for Curve Image 2.0 PACS, Substantially Equivalent on 2017-10-18. Applicant: Curve Dental, Ltd.. Device class: 2.

Clearance details

Applicant: Curve Dental, Ltd.
Product code: Code LLZ
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2017-09-29
Decision date: 2017-10-18
Decision: Substantially Equivalent
Clearance type: Special
Location: Calgary, CA

Download summary PDF View on FDA.gov ↗

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.