KrystalRad 11000 and KrystalRad 3000 Digital Stationary Radiographic System— 510(k) K143257

Name: FDA 510(k) clearance K143257
Creator: U.S. Food and Drug Administration
Published: 2015-02-06

Substantially Equivalent

Medicatech USA

FDA 510(k) clearance K143257 for KrystalRad 11000 and KrystalRad 3000 Digital Stationary Radiographic System, Substantially Equivalent on 2015-02-06. Applicant: Medicatech USA. Device class: 2.

Clearance details

Applicant: Medicatech USA
Product code: Code KPR
Device class: Class 2
Regulation: 21 CFR 892.1680
Advisory panel: Radiology
Date received: 2014-11-13
Decision date: 2015-02-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

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.