510(k) K013886
K013886 is an FDA 510(k) premarket notification submitted by Advanced Diagnostics, Inc. for the device "AVERA MODEL DEI SYSTEM (DIFFRACTIVE ENERGY IMAGING SYSTEM)". The FDA issued a decision of Substantially Equivalent on May 10, 2002. The device falls under product code NCS (System, Imaging, Holography, Acoustic), a Class II device regulated under 21 CFR 892.1550. Advanced Diagnostics, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 10, 2002
- Date Received
- November 23, 2001
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Imaging, Holography, Acoustic
- Device Class
- Class II
- Regulation Number
- 892.1550
- Review Panel
- RA
- Submission Type