I3SYSTEM-ABD— 510(k) K902007

Substantially Equivalent

Innovative Imaging, Inc.

FDA 510(k) clearance K902007 for I3SYSTEM-ABD, Substantially Equivalent on 1990-07-20. Applicant: Innovative Imaging, Inc..

Clearance details

Applicant: Innovative Imaging, Inc.
Product code: Code IYO
Advisory panel: Radiology
Date received: 1990-05-04
Decision date: 1990-07-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sacramento, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code IYO

product code IYO

Malfunction: 3,339
Total: 3,339

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.