LC POSITIONER— 510(k) K981414

Substantially Equivalent

Fischer Imaging Corp.

FDA 510(k) clearance K981414 for LC POSITIONER, Substantially Equivalent on 1998-07-16. Applicant: Fischer Imaging Corp..

Clearance details

Applicant: Fischer Imaging Corp.
Product code: Code JAA
Advisory panel: Radiology
Date received: 1998-04-20
Decision date: 1998-07-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Denver, CO, US

Download summary PDF View on FDA.gov ↗

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.