Device class
Class II
Regulation 892.2090
Total clearances
35
2020-03-05 → 2026-08-14
Definition
What is Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer
A radiological computer assisted detection and diagnostic software for suspected lesions is an image processing device intended to aid in the detection, localization, and characterization of lesions suspicious for cancer on acquired medical images (e.g., mammography , MR, CT, ultrasound, radiography). The device detects, identifies and characterizes lesions suspicious for cancer based on features or information extracted from the images, and may provide information about the presence, location, and characteristics of the lesion 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 |
| 76375 |
CPT
|
— |
Medium
|
Multiplanar reformatting of diagnostic imaging data for CAD |
| 76376 |
CPT
|
— |
Medium
|
3D rendering/manipulation of diagnostic source images for breast CAD |
| 76377 |
CPT
|
— |
Medium
|
Composite of multiple CT or MR images with 3D rendering for CAD analysis |
Pulse
Most recent 510(k) clearances
| Date | K-number | Sponsor | Device |
|---|
| 2026-08-14 |
K260898 |
Screenpoint Medical B.V.
|
Transpara (2.1.0) |
| 2026-08-12 |
K260086 |
BeamWorks, Inc.
|
CadAI-B Dx |
| 2026-07-28 |
K260303 |
See-Mode Technologies Pty, Ltd.
|
See-Mode Augmented Reporting Tool, Breast (SMART-B) |
| 2026-06-26 |
K260714 |
Therapixel
|
MammoScreen® (5) |
| 2026-06-15 |
K253825 |
DeepHealth, Inc.
|
Saige-Dx |
| 2026-04-29 |
K253682 |
Quantib B.V.
|
DeepHealth ProstateAI |
| 2026-04-23 |
K260320 |
Lunit, Inc.
|
Lunit INSIGHT MMG (v1.1.10) |
| 2026-03-26 |
K253796 |
Lunit, Inc.
|
Lunit INSIGHT DBT (V1.2) |
| 2026-02-06 |
K251474 |
Median Technologies
|
Median LCS (internal name) / eyonis LCS (trade name) (1.0) |
| 2025-08-11 |
K251873 |
DeepHealth, Inc.
|
Saige-Dx |
| 2025-07-31 |
K243341 |
Hologic, Inc.
|
Genius AI Detection 2.0 |
| 2025-07-03 |
K243679 |
Therapixel
|
MammoScreen® (4) |
| 2025-03-18 |
K242683 |
Quibim S.L.
|
QP-Prostate® CAD |
| 2025-03-05 |
K241770 |
Siemens Healthcare GmbH
|
Prostate MR AI (VA10A) |
| 2024-12-19 |
K243688 |
DeepHealth, Inc.
|
Saige-Dx (3.1.0) |
| 2024-11-25 |
K241831 |
Screenpoint Medical B.V.
|
Transpara (2.1.0) |
| 2024-11-18 |
K241747 |
DeepHealth, Inc.
|
Saige-Dx |
| 2024-11-08 |
K240417 |
Icad, Inc.
|
ProFound Detection (V4.0) |
| 2024-10-04 |
K242652 |
Lunit, Inc.
|
Lunit INSIGHT DBT v1.1 |
| 2024-09-09 |
K240697 |
See-Mode Technologies Pte, Ltd.
|
See-Mode Augmented Reporting Tool, Thyroid (SMART-T) |
| 2024-08-01 |
K240301 |
Therapixel
|
MammoScreen® (3) |
| 2023-11-06 |
K231470 |
Lunit, Inc.
|
Lunit INSIGHT DBT |
| 2023-05-23 |
K230096 |
Hologic, Inc.
|
Genius AI Detection 2.0 with CC-MLO Correlation |
| 2022-10-06 |
K221449 |
Hologic, Inc.
|
Genius AI Detection 2.0 |
| 2022-08-03 |
K221347 |
Screenpoint Medical B.V.
|
Transpara 1.7.2 |