IMPAX SE SIGMACOM CLIENT (PACS WORKSTATION)— 510(k) K071297

Name: FDA 510(k) clearance K071297
Creator: U.S. Food and Drug Administration
Published: 2007-06-22

Substantially Equivalent

Agfa Healthcare Corp.

FDA 510(k) clearance K071297 for IMPAX SE SIGMACOM CLIENT (PACS WORKSTATION), Substantially Equivalent on 2007-06-22. 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: 2007-05-09
Decision date: 2007-06-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Greenville, SC, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LLZ

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More clearances from Agfa Healthcare Corp.

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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 →

Recalls naming K071297

K-number listed on FDA's recall record

Z-0035-2014 — IMPAX 5.2 DB Server (running Oracle 10.1.0.4.0), medical imaging Picture Archiving and Communication System (PACS).Class II·Terminated·AGFA Corp.·20130919

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K071297.

Data sourced from openFDA. This site is unofficial and independent of the FDA.