STEREOTACTIC BODY FRAME, MODEL COD. 70-1A— 510(k) K031631

Name: FDA 510(k) clearance K031631
Creator: U.S. Food and Drug Administration
Published: 2003-07-18

Substantially Equivalent

3D Line USA, Inc.

FDA 510(k) clearance K031631 for STEREOTACTIC BODY FRAME, MODEL COD. 70-1A, Substantially Equivalent on 2003-07-18. Applicant: 3D Line USA, Inc.. Device class: 2.

Clearance details

Applicant: 3D Line USA, Inc.
Product code: Code IYE
Device class: Class 2
Regulation: 21 CFR 892.5050
Advisory panel: Radiology
Date received: 2003-05-27
Decision date: 2003-07-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Owings Mills, MD, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code IYE

product code IYE

Malfunction: 455
Other: 3
Total: 458

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.