Device class
Class II
Regulation 892.2060
Total clearances
21
2020-06-26 → 2026-07-02
Definition
What is Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer
Assist users in characterizing lesions identified on acquired medical images
Classification details
Medical specialty
Radiology
Regulation number
892.2060
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
|
— |
Low
|
MRI brain with contrast; for diagnostic imaging interpretation |
| 76881 |
CPT
|
— |
Low
|
Ultrasound, complete joint; real-time with image documentation |
Pulse
Most recent 510(k) clearances
| Date | K-number | Sponsor | Device |
|---|
| 2026-07-02 |
K253884 |
Koios Medical, Inc.
|
Koios DS (3.8) |
| 2026-06-04 |
K261519 |
Sonio
|
Sonio Suspect |
| 2026-03-27 |
K254161 |
GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC
|
Automated Aortic Stenosis Software (AutoAS) |
| 2026-01-30 |
K251769 |
Precision Medical Ventures, Inc. Dba Revealdx
|
RevealAI-Lung |
| 2025-12-08 |
K252294 |
Brightheart
|
Fetal EchoScan (v1.2) |
| 2025-07-01 |
K250221 |
Circle Cardiovascular Imaging, Inc.
|
StrokeSENS ASPECTS Software Application |
| 2025-05-02 |
K251071 |
Brightheart
|
Fetal EchoScan (v1.1) |
| 2025-02-21 |
K243614 |
Sonio
|
Sonio Suspect |
| 2025-02-14 |
K243294 |
Brainomix Limited
|
Brainomix 360 e-ASPECTS |
| 2024-11-15 |
K242130 |
Koios Medical, Inc.
|
Koios DS |
| 2024-11-14 |
K242342 |
Brightheart
|
Fetal EchoScan |
| 2024-10-04 |
K241245 |
Echo IQ, Ltd.
|
EchoSolv AS |
| 2024-08-01 |
K234141 |
Aisap
|
AISAP Cardio V1.0 |
| 2024-03-15 |
K233342 |
Avicenna.Ai
|
CINA-ASPECTS |
| 2024-01-19 |
K232156 |
Ischemaview, Inc.
|
Rapid ASPECTS (v3) |
| 2023-02-23 |
K221564 |
Brainomix Limited
|
Brainomix 360 e-ASPECTS |
| 2022-11-22 |
K221624 |
Avenda Health, Inc.
|
Avenda Health AI Prostate Cancer Planning Software |
| 2021-12-16 |
K212616 |
Koios Medical, Inc.
|
Koios DS |
| 2021-03-05 |
K202300 |
Optellum, Ltd.
|
Optellum Virtual Nodule Clinic, Optellum software, Optellum platform |
| 2020-12-18 |
K201555 |
Ultromics, Ltd.
|
EchoGo Pro |
| 2020-06-26 |
K200760 |
Ischemaview, Inc.
|
Rapid ASPECTS |