FDA product code NWE: Colon Computed Tomography System, Computer Aided Detection
NWE is the FDA product code for colon computed tomography system, computer aided detection. It is a Class II device, regulated under 21 CFR 892.2050 and reviewed by the Radiology panel. FDA has cleared 4 510(k) submissions under NWE, from 4 different applicants. The average 510(k) review took 295 days (median 128).
Definition
To assist radiologists in the review of multi-slice computed tomography (msct) exams of the colon and highlight potential polyps that the radiologist should review.
Classification
| Field | Value |
|---|---|
| Device name | Colon Computed Tomography System, Computer Aided Detection |
| Device class | Class II |
| Regulation | 21 CFR 892.2050 |
| Review panel | RA — Radiology |
| Medical specialty | Radiology |
| Premarket route | 510(k) |
Compare with all 510(k) review times · Search every NWE clearance
Top NWE applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Siemens Medical Solutions USA, Inc. | 1 | 2014-12-03 |
| Medicsight Plc | 1 | 2011-05-17 |
| Medicsight | 1 | 2004-10-19 |
| Siemens AG Medical Solutions | 1 | 2004-10-08 |
Most recent NWE clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K140920 | Siemens Medical Solutions USA, Inc. | SYNGO.CT COLONOGRAPHY | 2014-12-03 | 237 |
| K083423 | Medicsight Plc | COLONCAD API 3.1 | 2011-05-17 | 909 |
| K042674 | Medicsight | COLON CAR 1.2 | 2004-10-19 | 20 |
| K042605 | Siemens AG Medical Solutions | COLONGRAPHY SOFTWARE PACKAGE WITH EXTENDED FUNCTIONALITY | 2004-10-08 | 14 |
Recalls for NWE devices
openFDA lists no recalls for product code NWE.
Frequently asked questions
What is FDA product code NWE?
NWE is the FDA product code for colon computed tomography system, computer aided detection. It is a Class II device, regulated under 21 CFR 892.2050 and reviewed by the Radiology panel.
What device class is NWE?
Class II, regulation 21 CFR 892.2050. Typical premarket route: 510(k).
How long does a 510(k) take for product code NWE?
Across 4 cleared submissions the average was 295 days from receipt to decision (median 128).
Which companies have the most NWE clearances?
Siemens Medical Solutions USA, Inc. (1); Medicsight Plc (1); Medicsight (1); Siemens AG Medical Solutions (1).
Next steps
- Run an FDA pathway report with predicate devices for product code NWE
- Run a recall and safety report across every NWE manufacturer
- Watch product code NWE 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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