Device class
Class II
Regulation 892.2050
Total clearances
11
2020-03-09 → 2026-05-27
Definition
What is 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.
Classification details
Medical specialty
Radiology
Regulation number
892.2050
Trend
Clearance volume by quarter
Players
Top sponsors in this product code
Reimbursement
Likely billing codes (AI-inferred · verify with billing)
Healthcare providers using this device would typically bill under these HCPCS Level II
(alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku;
official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available.
Always verify with billing/coding teams before relying on these.
| Code | Type | Description | Confidence | Rationale |
| 71046 |
CPT
|
— |
Medium
|
CT chest with CAD for pulmonary nodule detection; computer-aided detection may be billed separately or bundled |
| 0174T |
CPT
|
— |
Low
|
Computer-aided detection CAD add-on code (older, may not apply to CT lung systems) |
Pulse
Most recent 510(k) clearances