Device class
Class II
Regulation 870.2200
Total clearances
3
2024-11-15 → 2025-06-20
Definition
What is Adjunctive Cardiac Amyloidosis Status Indicator
The adjunctive cardiac amyloidosis status indicator is a prescription device based on sensor technology or image data to provide information to an interpreting clinician in detecting cardiac amyloidosis. This device is intended for adjunctive use with other physical vital sign parameters and patient information and is not intended to independently direct therapy.
Classification details
Medical specialty
Cardiovascular
Regulation number
870.2200
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 |
| 93040 |
CPT
|
— |
Low
|
Cardiac indicator device; adjunctive amyloidosis detection may use echocardiography or imaging-based billing codes |
Pulse
Most recent 510(k) clearances