AS-OBGYN INFORMATION SYSTEM; AS-EMR SYSTEM— 510(k) K051639

Name: FDA 510(k) clearance K051639
Creator: U.S. Food and Drug Administration
Published: 2005-08-02

Substantially Equivalent

As Software, Inc.

FDA 510(k) clearance K051639 for AS-OBGYN INFORMATION SYSTEM; AS-EMR SYSTEM, Substantially Equivalent on 2005-08-02. Applicant: As Software, Inc.. Device class: 2.

Clearance details

Applicant: As Software, Inc.
Product code: Code LLZ
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2005-06-20
Decision date: 2005-08-02
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Englewood, NJ, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LLZ

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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 K051639

K-number listed on FDA's recall record

Z-0118-2019 — AS-OBGYN Information System version 7.824.xClass II·Terminated·AS Software, Inc.·20180920

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K051639.

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