UNISCAN, PULMOSCAN, PULMOSCAN RADIOGRAPHIC SYSTEMS— 510(k) K033577

Substantially Equivalent

Medlink Imaging

FDA 510(k) clearance K033577 for UNISCAN, PULMOSCAN, PULMOSCAN RADIOGRAPHIC SYSTEMS, Substantially Equivalent on 2005-03-18. Applicant: Medlink Imaging.

Clearance details

Applicant: Medlink Imaging
Product code: Code KPR
Advisory panel: Radiology
Date received: 2003-11-13
Decision date: 2005-03-18
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Deer Field, IL, US

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Adverse events under product code KPR

product code KPR

Other: 6
Total: 6

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.