MR-GUIDE 2000— 510(k) K013150

Substantially Equivalent

Ultraguide , Ltd.

FDA 510(k) clearance K013150 for MR-GUIDE 2000, Substantially Equivalent on 2001-10-18. Applicant: Ultraguide , Ltd..

Clearance details

Applicant: Ultraguide , Ltd.
Product code: Code LNH
Advisory panel: Radiology
Date received: 2001-09-20
Decision date: 2001-10-18
Decision: Substantially Equivalent
Clearance type: Special
Location: Hasbrouck Heights, NJ, US

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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.