510(k) K051639
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