FDA product code NCS: System, Imaging, Holography, Acoustic
NCS is the FDA product code for system, imaging, holography, acoustic. It is a Class II device, regulated under 21 CFR 892.1550 and reviewed by the Radiology panel. FDA has cleared 3 510(k) submissions under NCS. The average 510(k) review took 137 days (median 168).
Classification
| Field | Value |
|---|---|
| Device name | System, Imaging, Holography, Acoustic |
| Device class | Class II |
| Regulation | 21 CFR 892.1550 |
| Review panel | RA — Radiology |
| Medical specialty | Radiology |
| Premarket route | 510(k) |
Compare with all 510(k) review times · Search every NCS clearance
Top NCS applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Advanced Diagnostics, Inc. | 3 | 2002-05-10 |
Most recent NCS clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K013886 | Advanced Diagnostics, Inc. | AVERA MODEL DEI SYSTEM (DIFFRACTIVE ENERGY IMAGING SYSTEM) | 2002-05-10 | 168 |
| K013291 | Advanced Diagnostics, Inc. | ALTAIR MODEL, DEI SYSTEM (DIFFRACTIVE ENERGY IMAGING SYSTEM) | 2001-11-14 | 43 |
| K001510 | Advanced Diagnostics, Inc. | OS-2000 OPTICAL SONOGRAPHY SYSTEM | 2000-11-30 | 199 |
Recalls for NCS devices
openFDA lists no recalls for product code NCS.
Frequently asked questions
What is FDA product code NCS?
NCS is the FDA product code for system, imaging, holography, acoustic. It is a Class II device, regulated under 21 CFR 892.1550 and reviewed by the Radiology panel.
What device class is NCS?
Class II, regulation 21 CFR 892.1550. Typical premarket route: 510(k).
How long does a 510(k) take for product code NCS?
Across 3 cleared submissions the average was 137 days from receipt to decision (median 168).
Which companies have the most NCS clearances?
Advanced Diagnostics, Inc. (3).
Next steps
- Run an FDA pathway report with predicate devices for product code NCS
- Run a recall and safety report across every NCS manufacturer
- Watch product code NCS for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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