SpeqRT— 510(k) K152250

Substantially Equivalent

Signostics Limited

FDA 510(k) clearance K152250 for SpeqRT, Substantially Equivalent on 2015-09-03. Applicant: Signostics Limited.

Clearance details

Applicant: Signostics Limited
Product code: Code IYN
Advisory panel: Radiology
Date received: 2015-08-10
Decision date: 2015-09-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Clovelly Park, AU

Download summary PDF View on FDA.gov ↗

Adverse events under product code IYN

product code IYN

Death: 25
Injury: 163
Malfunction: 1,538
Other: 4
Total: 1,730

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.