G.E. AMX 110, AMX II AND AMX 3 X-RAY UNITS— 510(k) K902984

Substantially Equivalent

Electromek Diagnostic Systems, Inc.

FDA 510(k) clearance K902984 for G.E. AMX 110, AMX II AND AMX 3 X-RAY UNITS, Substantially Equivalent on 1990-10-26. Applicant: Electromek Diagnostic Systems, Inc..

Clearance details

Applicant: Electromek Diagnostic Systems, Inc.
Product code: Code IZL
Advisory panel: Radiology
Date received: 1990-06-26
Decision date: 1990-10-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Troy, IL, US

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Adverse events under product code IZL

product code IZL

Other: 3
Total: 3

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.