Modus IR— 510(k) K231986

Substantially Equivalent

Synaptive Medical, Inc.

FDA 510(k) clearance K231986 for Modus IR, Substantially Equivalent on 2024-03-25. Applicant: Synaptive Medical, Inc..

Clearance details

Applicant: Synaptive Medical, Inc.
Product code: Code IZI
Advisory panel: Radiology
Date received: 2023-07-05
Decision date: 2024-03-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Toronto, CA

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.