HRSW OPTION FOR CT TWIN FLASH— 510(k) K945512

Substantially Equivalent

Elscint, Inc.

FDA 510(k) clearance K945512 for HRSW OPTION FOR CT TWIN FLASH, Substantially Equivalent on 1995-03-14. Applicant: Elscint, Inc..

Clearance details

Applicant: Elscint, Inc.
Product code: Code JAK
Advisory panel: Radiology
Date received: 1994-11-09
Decision date: 1995-03-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hackensack, NJ, 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.