CADSTREAM VERSION 3.1— 510(k) K041020

Name: FDA 510(k) clearance K041020
Creator: U.S. Food and Drug Administration
Published: 2004-07-07

Substantially Equivalent

Confirma, Inc.

FDA 510(k) clearance K041020 for CADSTREAM VERSION 3.1, Substantially Equivalent on 2004-07-07. Applicant: Confirma, Inc.. Device class: 2.

Clearance details

Applicant: Confirma, Inc.
Product code: Code LNH
Device class: Class 2
Regulation: 21 CFR 892.1000
Advisory panel: Radiology
Date received: 2004-04-20
Decision date: 2004-07-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kirkland, WA, US

Download summary PDF View on FDA.gov ↗

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K060547 — ACCESS BREAST COIL 4/SMS2006-03-29
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Adverse events under product code LNH

product code LNH

Death: 11
Injury: 670
Malfunction: 1,460
Other: 2
Total: 2,143

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.