NCS — System, Imaging, Holography, Acoustic Class II
FDA product code NCS covers "System, Imaging, Holography, Acoustic", a Class II medical device regulated under 21 CFR 892.1550. Submissions are reviewed by the Radiology panel. At least 3 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- NCS
- Device Class
- Class II
- Regulation Number
- 892.1550
- Submission Type
- Review Panel
- RA
- Medical Specialty
- Radiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K013886 | advanced diagnostics | AVERA MODEL DEI SYSTEM (DIFFRACTIVE ENERGY IMAGING SYSTEM) | May 10, 2002 |
| K013291 | advanced diagnostics | ALTAIR MODEL, DEI SYSTEM (DIFFRACTIVE ENERGY IMAGING SYSTEM) | November 14, 2001 |
| K001510 | advanced diagnostics | OS-2000 OPTICAL SONOGRAPHY SYSTEM | November 30, 2000 |