ArtPix Mobile EZ2GO— 510(k) K162224

Substantially Equivalent

Cmt Medical Technologies, Ltd.

FDA 510(k) clearance K162224 for ArtPix Mobile EZ2GO, Substantially Equivalent on 2016-09-22. Applicant: Cmt Medical Technologies, Ltd..

Clearance details

Applicant: Cmt Medical Technologies, Ltd.
Product code: Code KPR
Advisory panel: Radiology
Date received: 2016-08-08
Decision date: 2016-09-22
Decision: Substantially Equivalent
Clearance type: Special
Location: Yoqneam Ilit, IL

Download summary PDF View on FDA.gov ↗

Adverse events under product code KPR

product code KPR

Other: 6
Total: 6

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.