QUANTIMAP III— 510(k) K863650

Substantially Equivalent

Quantified Signal Imaging, Inc.

FDA 510(k) clearance K863650 for QUANTIMAP III, Substantially Equivalent on 1986-09-26. Applicant: Quantified Signal Imaging, Inc..

Clearance details

Applicant: Quantified Signal Imaging, Inc.
Product code: Code OLT
Advisory panel: Neurology
Date received: 1986-09-18
Decision date: 1986-09-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Toronto, CA

Download summary PDF View on FDA.gov ↗

Adverse events under product code OLT

product code OLT

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.