MST-1050-II X-RAY UNIT— 510(k) K853210

Name: FDA 510(k) clearance K853210
Creator: U.S. Food and Drug Administration
Published: 1985-10-10

Substantially Equivalent

Radiological Engineering, Inc.

FDA 510(k) clearance K853210 for MST-1050-II X-RAY UNIT, Substantially Equivalent on 1985-10-10. Applicant: Radiological Engineering, Inc.. Device class: 1.

Clearance details

Applicant: Radiological Engineering, Inc.
Product code: Code KPA
Device class: Class 1
Regulation: 21 CFR 864.3800
Advisory panel: Pathology
Date received: 1985-07-31
Decision date: 1985-10-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North Ft. Myers, FL, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code KPA

product code KPA

Malfunction: 1,177
Total: 1,177

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.