Colon Computed Tomography System, Computer Aided Detection

NWE · Class II — Moderate Risk (510(k) clearance required) · Radiology · 21 CFR 892.2050

Classification

FDA Product Code: NWE
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 892.2050
Review panel: RA
Medical specialty: Radiology
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

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.

Market data

Cleared 510(k) submissions: 4
Registered establishments: 1

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown