ORTHO SOFTWARE USED W/LUNAR DPX/DPX-L/DPS-@ DESIT— 510(k) K914404

Substantially Equivalent

Lunar

FDA 510(k) clearance K914404 for ORTHO SOFTWARE USED W/LUNAR DPX/DPX-L/DPS-@ DESIT, Substantially Equivalent on 1992-02-27. Applicant: Lunar.

Clearance details

Applicant: Lunar
Product code: Code KGI
Advisory panel: Radiology
Date received: 1991-10-03
Decision date: 1992-02-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Madison, WI, US

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Adverse events under product code KGI

product code KGI

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.