NCS
3 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- System, Imaging, Holography, Acoustic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 892.1550
- Medical specialty
- Radiology
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| AVERA MODEL DEI SYSTEM (DIFFRACTIVE ENERGY IMAGING SYSTEM) (K013886) | Advanced Diagnostics, Inc. | 2002-05-10 |
| ALTAIR MODEL, DEI SYSTEM (DIFFRACTIVE ENERGY IMAGING SYSTEM) (K013291) | Advanced Diagnostics, Inc. | 2001-11-14 |
| OS-2000 OPTICAL SONOGRAPHY SYSTEM (K001510) | Advanced Diagnostics, Inc. | 2000-11-30 |
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Every clearance here is in the API, with alerts when new ones post.