N-VIVO CALCIUM SCORE ON IA CHASSIS RELEASE, MODEL RELEASE X.XX— 510(k) K040782

Substantially Equivalent

Image Analysis, Inc.

FDA 510(k) clearance K040782 for N-VIVO CALCIUM SCORE ON IA CHASSIS RELEASE, MODEL RELEASE X.XX, Substantially Equivalent on 2004-07-13. Applicant: Image Analysis, Inc..

Clearance details

Applicant: Image Analysis, Inc.
Product code: Code JAK
Advisory panel: Radiology
Date received: 2004-03-26
Decision date: 2004-07-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Columbia, KY, 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.