510(k) K013886
- Device
- AVERA MODEL DEI SYSTEM (DIFFRACTIVE ENERGY IMAGING SYSTEM)
- Applicant
- Advanced Diagnostics, Inc.
- 510(k) number
- K013886
- Product code
- NCS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2002-05-10
- Date received
- 2001-11-23
- Regulation
- 892.1550
- Classification name
- System, Imaging, Holography, Acoustic
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- STEVE HESSLER
- Address
- 8112 304th Ave. Se. Preston WA US 98050 98050