ISYS 1 (U.S),ACCESSORY, NON-STERILE— 510(k) K131433

Substantially Equivalent

Isys Medizintechnik GmbH

FDA 510(k) clearance K131433 for ISYS 1 (U.S),ACCESSORY, NON-STERILE, Substantially Equivalent on 2014-03-11. Applicant: Isys Medizintechnik GmbH.

Clearance details

Applicant: Isys Medizintechnik GmbH
Product code: Code JAK
Advisory panel: Radiology
Date received: 2013-05-17
Decision date: 2014-03-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Stamford, CT, 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.