ORTHOPEDIC SOFTWARE FOR IMPAX WORKSTATIONS— 510(k) K071972

Name: FDA 510(k) clearance K071972
Creator: U.S. Food and Drug Administration
Published: 2007-07-30

Substantially Equivalent

Agfa Healthcare Corp.

FDA 510(k) clearance K071972 for ORTHOPEDIC SOFTWARE FOR IMPAX WORKSTATIONS, Substantially Equivalent on 2007-07-30. Applicant: Agfa Healthcare Corp.. Device class: 2.

Clearance details

Applicant: Agfa Healthcare Corp.
Product code: Code LLZ
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2007-07-17
Decision date: 2007-07-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Greenville, SC, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LLZ

view all

More clearances from Agfa Healthcare Corp.

view all

Adverse events under product code LLZ

product code LLZ

Death: 13
Total: 13

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.