CLIMB MAMMOGRAPHY VIEWER SOFTWARE— 510(k) K141364

Substantially Equivalent

Climb Medical Systems, Inc.

FDA 510(k) clearance K141364 for CLIMB MAMMOGRAPHY VIEWER SOFTWARE, Substantially Equivalent on 2014-08-29. Applicant: Climb Medical Systems, Inc..

Clearance details

Applicant: Climb Medical Systems, Inc.
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2014-05-23
Decision date: 2014-08-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Toyonaka-Shi, Osaka, JP

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.