ECHOSTAR SPICA 1.5T MR SYSTEM— 510(k) K113511

Substantially Equivalent

Alltech Medical Systems America, Inc.

FDA 510(k) clearance K113511 for ECHOSTAR SPICA 1.5T MR SYSTEM, Substantially Equivalent on 2012-05-02. Applicant: Alltech Medical Systems America, Inc..

Clearance details

Applicant: Alltech Medical Systems America, Inc.
Product code: Code LNH
Advisory panel: Radiology
Date received: 2011-11-28
Decision date: 2012-05-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Solon, OH, 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.