510(k) K051639

AS-OBGYN INFORMATION SYSTEM; AS-EMR SYSTEM by As Software, Inc. — Product Code LLZ

K051639 is an FDA 510(k) premarket notification submitted by As Software, Inc. for the device "AS-OBGYN INFORMATION SYSTEM; AS-EMR SYSTEM". The FDA issued a decision of Substantially Equivalent on August 2, 2005. The device falls under product code LLZ (System, Image Processing, Radiological), a Class II device regulated under 21 CFR 892.2050. As Software, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 2, 2005
Date Received
June 20, 2005
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Image Processing, Radiological
Device Class
Class II
Regulation Number
892.2050
Review Panel
RA
Submission Type