Device class
Class II
Regulation 892.2085
Total clearances
4
2024-01-12 → 2025-11-07
Definition
What is Radiology Software For Referral Of Findings Related To Fibrotic Lung Disease.
Radiology software for referral of findings related to fibrotic lung disease is a prescription image processing device that analyzes computed tomography images to suggest the presence of disease or of an imaging finding suggestive of disease. The output of this device is intended to be used as adjunctive information as part of a referral pathway in the overall diagnostic assessment process.
Classification details
Medical specialty
Radiology
Regulation number
892.2085
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 |
| 70553 |
CPT
|
— |
Medium
|
Computed tomography, chest and abdomen; with contrast material(s) |
| 76376 |
CPT
|
— |
Medium
|
3D rendering with interpretation and reporting of computed tomography or magnetic resonance data |
Pulse
Most recent 510(k) clearances