ICRCO CLARITY VIEWER— 510(k) K132499

Substantially Equivalent

Icrco, Inc.

FDA 510(k) clearance K132499 for ICRCO CLARITY VIEWER, Substantially Equivalent on 2014-01-21. Applicant: Icrco, Inc..

Clearance details

Applicant: Icrco, Inc.
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2013-08-09
Decision date: 2014-01-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Torrance, CA, US

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.