OEB · Class II — Moderate Risk (510(k) clearance required) · Radiology · 21 CFR 892.2050
Classification
FDA Product Code
OEB
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 chest and highlight potential nodules that the radiologist should review. A computer aided diagnosis, lung computed tomography system is a class 3 device under product code NRR.