510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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NWEClass II

Colon Computed Tomography System, Computer Aided Detection

21 CFR 892.2050 / Radiology
FDA source (opens on fda.gov)

NWE is the FDA product code for Colon Computed Tomography System, Computer Aided Detection, a class II device type, regulated under 21 CFR 892.2050. FDA's definition for this code reads: "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". As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
NWE
Device name
Colon Computed Tomography System, Computer Aided Detection
FDA 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.
Regulation
21 CFR 892.2050
Device class
Class II
Review panel
Radiology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
4
Ingested recalls
0

Clearances, product code NWE

By decision year
4 clearances under product code NWE with a decision year between 2004 and 2014, 2004 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code NWE by decision year
YearClearances
20042
20111
20141

Applicants with the most clearances

Product code NWE
Applicants holding the most 510(k) clearances under product code NWE
ApplicantClearances
Medicsight2
Siemens AG Medical Solutions1
Siemens Medical Solutions USA, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code