Device class
—
Regulation —
Total clearances
21
2020-06-26 → 2026-07-02
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 |