ND1100 BONE DENSITY SCANNER— 510(k) K881383

Name: FDA 510(k) clearance K881383
Creator: U.S. Food and Drug Administration
Published: 1989-05-22

Substantially Equivalent

Nuclear Data, Inc.

FDA 510(k) clearance K881383 for ND1100 BONE DENSITY SCANNER, Substantially Equivalent on 1989-05-22. Applicant: Nuclear Data, Inc.. Device class: 2.

Clearance details

Applicant: Nuclear Data, Inc.
Product code: Code KGI
Device class: Class 2
Regulation: 21 CFR 892.1170
Advisory panel: Radiology
Date received: 1988-04-01
Decision date: 1989-05-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Schaumburg, IL, 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.