← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · CLASS II

OEB — Lung Computed Tomography System, Computer-Aided Detection

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.

DEVICE CLASS
Class II
REGULATION
21 CFR 892.2050
MEDICAL SPECIALTY
Radiology
REVIEW PANEL
RA
— Implant— Life-sustaining— GMP-exempt— Third-party review eligible
4
510(K)/PMA CLEARANCES
510k: 4
0
RECALL ENTRIES

Recent clearances

K254075Fujifilm Corporation · 510k2026-05-27
K251203Coreline Soft Co., Ltd. · 510k2025-12-03
K240554Infervision Medical Technology Co., Ltd. · 510k2025-05-16
K242919V5med, Inc. · 510k2025-03-27

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →