SKANRAD 400— 510(k) K220518

Substantially Equivalent

Skanray Technologies Limited

FDA 510(k) clearance K220518 for SKANRAD 400, Substantially Equivalent on 2022-04-01. Applicant: Skanray Technologies Limited.

Clearance details

Applicant: Skanray Technologies Limited
Product code: Code KPR
Advisory panel: Radiology
Date received: 2022-02-23
Decision date: 2022-04-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mysore, IN

Download summary PDF View on FDA.gov ↗

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.