PET-SCOPE II MODEL DIS-1611— 510(k) K801166

Substantially Equivalent

Diagnostic Information, Inc.

FDA 510(k) clearance K801166 for PET-SCOPE II MODEL DIS-1611, Substantially Equivalent on 1980-06-26. Applicant: Diagnostic Information, Inc..

Clearance details

Applicant: Diagnostic Information, Inc.
Product code: Code JAA
Advisory panel: Radiology
Date received: 1980-05-16
Decision date: 1980-06-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code JAA

product code JAA

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.