RADspeed fit— 510(k) K173517

Substantially Equivalent

Shimadzu Corporation

FDA 510(k) clearance K173517 for RADspeed fit, Substantially Equivalent on 2018-03-30. Applicant: Shimadzu Corporation.

Clearance details

Applicant: Shimadzu Corporation
Product code: Code KPR
Advisory panel: Radiology
Date received: 2017-11-14
Decision date: 2018-03-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kyoto, JP

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.