LATERAL SPINE OPT. XR-SERIES X-RAY BONE DENSITOMET— 510(k) K913078

Substantially Equivalent

Norland Corp.

FDA 510(k) clearance K913078 for LATERAL SPINE OPT. XR-SERIES X-RAY BONE DENSITOMET, Substantially Equivalent on 1991-09-24. Applicant: Norland Corp..

Clearance details

Applicant: Norland Corp.
Product code: Code KGI
Advisory panel: Radiology
Date received: 1991-07-11
Decision date: 1991-09-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fort Atkinson, 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.