X-RAY MONOBLOCK, MONOBLOCK XRS-60-330— 510(k) K000052

Name: FDA 510(k) clearance K000052
Creator: U.S. Food and Drug Administration
Published: 2000-02-10

Substantially Equivalent

Dynarad Corp.

FDA 510(k) clearance K000052 for X-RAY MONOBLOCK, MONOBLOCK XRS-60-330, Substantially Equivalent on 2000-02-10. Applicant: Dynarad Corp.. Device class: 1.

Clearance details

Applicant: Dynarad Corp.
Product code: Code ITY
Device class: Class 1
Regulation: 21 CFR 892.1760
Advisory panel: Radiology
Date received: 2000-01-07
Decision date: 2000-02-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Deer Park, NY, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code ITY

product code ITY

Other: 1
Total: 1

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.