Product code NCS
- Device name
- System, Imaging, Holography, Acoustic
- Medical specialty
- Radiology
- Device class
- 2
- Regulation number
- 892.1550
- Review panel
- RA
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records
| 510(k) | Device | Applicant | Decision date |
|---|
| K013886 | AVERA MODEL DEI SYSTEM (DIFFRACTIVE ENERGY IMAGING SYSTEM) | Advanced Diagnostics, Inc. | 2002-05-10 |
| K013291 | ALTAIR MODEL, DEI SYSTEM (DIFFRACTIVE ENERGY IMAGING SYSTEM) | Advanced Diagnostics, Inc. | 2001-11-14 |
| K001510 | OS-2000 OPTICAL SONOGRAPHY SYSTEM | Advanced Diagnostics, Inc. | 2000-11-30 |