PIXI YOUNG ADULT REFERENC POPULATION FOR OS CALCIS AND FOREARM— 510(k) K972053

Substantially Equivalent

Lunar Corp.

FDA 510(k) clearance K972053 for PIXI YOUNG ADULT REFERENC POPULATION FOR OS CALCIS AND FOREARM, Substantially Equivalent on 1997-08-08. Applicant: Lunar Corp..

Clearance details

Applicant: Lunar Corp.
Product code: Code KGI
Advisory panel: Radiology
Date received: 1997-06-02
Decision date: 1997-08-08
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.