NDI MODEL IRS-TD— 510(k) K904676

Substantially Equivalent

National Diagnostic Imaging, Inc.

FDA 510(k) clearance K904676 for NDI MODEL IRS-TD, Substantially Equivalent on 1991-06-21. Applicant: National Diagnostic Imaging, Inc..

Clearance details

Applicant: National Diagnostic Imaging, Inc.
Product code: Code KPR
Advisory panel: Radiology
Date received: 1990-10-12
Decision date: 1991-06-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Vienna, VA, US

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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.