SYNC-RX SYSTEM, MODEL AS00010— 510(k) K100849

Substantially Equivalent

Sync-Rx, Ltd.

FDA 510(k) clearance K100849 for SYNC-RX SYSTEM, MODEL AS00010, Substantially Equivalent on 2010-05-21. Applicant: Sync-Rx, Ltd..

Clearance details

Applicant: Sync-Rx, Ltd.
Product code: Code IZI
Advisory panel: Radiology
Date received: 2010-03-26
Decision date: 2010-05-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lakewood, CO, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code IZI

product code IZI

Death: 9
Malfunction: 5,312
Total: 5,321

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.