SECTRA OSTEOPOROSIS PACKAGE— 510(k) K021527

Name: FDA 510(k) clearance K021527
Creator: U.S. Food and Drug Administration
Published: 2002-06-07

Substantially Equivalent

Sectra-Imtec AB

FDA 510(k) clearance K021527 for SECTRA OSTEOPOROSIS PACKAGE, Substantially Equivalent on 2002-06-07. Applicant: Sectra-Imtec AB. Device class: 2.

Clearance details

Applicant: Sectra-Imtec AB
Product code: Code KGI
Device class: Class 2
Regulation: 21 CFR 892.1170
Advisory panel: Radiology
Date received: 2002-05-10
Decision date: 2002-06-07
Decision: Substantially Equivalent
Clearance type: Special
Location: Denton, TX, US

Download summary PDF View on FDA.gov ↗

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K063093 — SECTRA WORKSTATION, VERSION 11.12006-11-07
K051315 — MODIFICATION TO: SECTRA IDS5 WORKSTATION2005-06-15
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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.