INREACH SYSTEM, MODEL AAS00161-02— 510(k) K092365

Substantially Equivalent

Superdimension, Ltd.

FDA 510(k) clearance K092365 for INREACH SYSTEM, MODEL AAS00161-02, Substantially Equivalent on 2009-09-04. Applicant: Superdimension, Ltd..

Clearance details

Applicant: Superdimension, Ltd.
Product code: Code JAK
Advisory panel: Radiology
Date received: 2009-08-05
Decision date: 2009-09-04
Decision: Substantially Equivalent
Clearance type: Special
Location: Plymouth, MN, US

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Adverse events under product code JAK

product code JAK

Death: 27
Injury: 571
Malfunction: 779
Total: 1,377

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.