COMPUTED TOMOGRAPHY COUCH PAD FOR MIN ANALYSIS— 510(k) K852510

Substantially Equivalent

Image Analysis, Inc.

FDA 510(k) clearance K852510 for COMPUTED TOMOGRAPHY COUCH PAD FOR MIN ANALYSIS, Substantially Equivalent on 1985-10-18. Applicant: Image Analysis, Inc..

Clearance details

Applicant: Image Analysis, Inc.
Product code: Code KGI
Advisory panel: Radiology
Date received: 1985-06-12
Decision date: 1985-10-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

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Adverse events under product code KGI

product code KGI

Other: 1
Total: 1

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.