SMARTSPOT PRIMAX— 510(k) K080890

Substantially Equivalent

Cmt Medical Technologies, Ltd.

FDA 510(k) clearance K080890 for SMARTSPOT PRIMAX, Substantially Equivalent on 2008-04-29. Applicant: Cmt Medical Technologies, Ltd..

Clearance details

Applicant: Cmt Medical Technologies, Ltd.
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2008-03-31
Decision date: 2008-04-29
Decision: Substantially Equivalent
Clearance type: Special
Location: Haifa, IL

Download summary PDF View on FDA.gov ↗

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.