DEXACARE G4— 510(k) K021331

Substantially Equivalent

Osteometer Meditech, Inc.

FDA 510(k) clearance K021331 for DEXACARE G4, Substantially Equivalent on 2002-05-21. Applicant: Osteometer Meditech, Inc..

Clearance details

Applicant: Osteometer Meditech, Inc.
Product code: Code KGI
Advisory panel: Radiology
Date received: 2002-04-26
Decision date: 2002-05-21
Decision: Substantially Equivalent
Clearance type: Special
Location: Hawthorne, CA, US

Download summary PDF View on FDA.gov ↗

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.