Device class
Class II
Regulation 892.2100
Total clearances
9
2020-02-07 → 2026-07-15
Definition
What is Image Acquisition And/Or Optimization Guided By Artificial Intelligence
A radiological acquisition and/or optimization guidance system is a device that is intended to aid in the acquisition and/or optimization of images and/or diagnostic signals. The device interfaces with the acquisition system, analyzes its output, and provides guidance and/or feedback to the operator for improving image and/or signal quality.
Classification details
Medical specialty
Radiology
Regulation number
892.2100
Trend
Clearance volume by quarter
Players
Top sponsors in this product code
| Sponsor |
Clearances |
Last 12 mo |
Most recent |
|
Caption Health
|
3 |
0 |
2025-01-15 |
|
Ultrasight , Ltd.
|
2 |
1 |
2025-12-17 |
|
Deski |
2 |
1 |
2026-06-03 |
|
Bay Labs, Inc. |
1 |
0 |
2020-02-07 |
|
ThinkSono GmbH |
1 |
1 |
2026-07-15 |
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 |
| 76376 |
CPT
|
— |
Medium
|
3D image reconstruction/processing for radiology; applicable for AI-guided acquisition |
| 76998 |
CPT
|
— |
Medium
|
Ultrasound guidance software/AI optimization may be ancillary to imaging codes |
Pulse
Most recent 510(k) clearances