DigiX FDX— 510(k) K192541

Name: FDA 510(k) clearance K192541
Creator: U.S. Food and Drug Administration
Published: 2019-10-16

Substantially Equivalent

Allengers Medical Systems Limited

FDA 510(k) clearance K192541 for DigiX FDX, Substantially Equivalent on 2019-10-16. Applicant: Allengers Medical Systems Limited. Device class: 2.

Clearance details

Applicant: Allengers Medical Systems Limited
Product code: Code KPR
Device class: Class 2
Regulation: 21 CFR 892.1680
Advisory panel: Radiology
Date received: 2019-09-16
Decision date: 2019-10-16
Decision: Substantially Equivalent
Clearance type: Special
Location: Derabassi, Distt Mohali, IN

Download summary PDF View on FDA.gov ↗

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Adverse events under product code KPR

product code KPR

Other: 6
Total: 6

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.