Device class
Class II
Regulation 892.2090
Total clearances
10
2020-07-30 → 2026-08-28
Definition
What is Radiological Computer Assisted Detection/Diagnosis Software For Fracture
A radiological computer assisted detection and diagnostic software for suspected fracture is an image processing device intended to aid in the detection, localization, and/or characterization of fracture on acquired medical images (e.g. radiography, MR, CT). The device detects, identifies and/or characterizes fracture based on features or information extracted from images, and may provide information about the presence, location, and/or characteristics of the fracture to the user. Primary diagnostic and patient management decisions are made by the clinical user.
Classification details
Medical specialty
Radiology
Regulation number
892.2090
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 |
| 70450 |
CPT
|
— |
Low
|
CT head/brain; computer assisted detection may accompany imaging |
| 71020 |
CPT
|
— |
Low
|
Chest radiography; CAD software applies to radiography |
| 99457 |
CPT
|
— |
Low
|
Remote monitoring/clinical assessment; may support diagnostic interpretation |
Pulse
Most recent 510(k) clearances