FDA.report

510(k) K051639

Device
AS-OBGYN INFORMATION SYSTEM; AS-EMR SYSTEM
Applicant
AS SOFTWARE, INC.
510(k) number
K051639
Product code
LLZ  
Decision
Substantially Equivalent (SESE)
Decision date
2005-08-02
Date received
2005-06-20
Regulation
892.2050
Classification name
System, Image Processing, Radiological
Medical specialty
Radiology
Review panel
Radiology
Device class
2
Clearance type
Abbreviated
Statement or summary
Summary
Third party reviewed
No
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
KIM A NATHANSON
Address
80 S. Woodland St. Englewood NJ US 07631 07631

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

Related GUDID Devices

Primary DIBrandCompanyPublished
00860010575314AS SoftwareAs Software, LLC2026-03-10
00860010575307AS-EMR SYSTEM; AS-OBGYN INFORMATION SYSTEMAs Software, LLC2023-07-13

Legacy Summary

summary

FDA Review

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