ArtPIX DRF— 510(k) K202235

Substantially Equivalent

Cmt Medical Technologies, Ltd.

FDA 510(k) clearance K202235 for ArtPIX DRF, Substantially Equivalent on 2020-09-03. Applicant: Cmt Medical Technologies, Ltd..

Clearance details

Applicant: Cmt Medical Technologies, Ltd.
Product code: Code JAA
Advisory panel: Radiology
Date received: 2020-08-07
Decision date: 2020-09-03
Decision: Substantially Equivalent
Clearance type: Special
Location: Yokneam Ilit, IL

Download summary PDF View on FDA.gov ↗

Adverse events under product code JAA

product code JAA

Other: 1
Total: 1

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.