DIGITAL DIAGNOSTIC X-RAY SYSTEM, MODELS MAK 1500, MAK 2000 AND MAK 3000— 510(k) K082798

Name: FDA 510(k) clearance K082798
Creator: U.S. Food and Drug Administration
Published: 2008-10-28

Substantially Equivalent

Medicatech USA

FDA 510(k) clearance K082798 for DIGITAL DIAGNOSTIC X-RAY SYSTEM, MODELS MAK 1500, MAK 2000 AND MAK 3000, Substantially Equivalent on 2008-10-28. 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: 2008-09-23
Decision date: 2008-10-28
Decision: Substantially Equivalent
Clearance type: Special
Location: Deer Field, IL, 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.