Device class
Class II
Regulation 892.2050
Total clearances
332
2020-03-25 → 2026-09-25
Definition
What is Automated Radiological Image Processing Software
To provide automated radiological image processing and analysis tools. Software implementing artificial intelligence including nonadaptive machine learning algorithms trained with clinical and/or artificial data. In these devices, the algorithm training data typically impacts device performance. Adaptive AI algorithms are not within scope of this product code.
Classification details
Medical specialty
Radiology
Regulation number
892.2050
Trend
Clearance volume by quarter
Players
Top sponsors in this product code
| Sponsor |
Clearances |
Last 12 mo |
Most recent |
|
Siemens Medical Solutions USA, Inc.
|
13 |
4 |
2026-09-25 |
|
Dia Imaging Analysis, Ltd.
|
10 |
0 |
2025-03-17 |
|
Shanghai United Imaging Healthcare Co., Ltd.
|
6 |
1 |
2026-04-22 |
|
Ischemaview, Inc.
|
6 |
1 |
2026-09-21 |
|
Overjet, Inc.
|
5 |
2 |
2026-04-10 |
|
Siemens Healthcare GmbH
|
5 |
2 |
2026-04-10 |
|
Clarius Mobile Health Corp.
|
5 |
1 |
2026-03-02 |
|
Aidoc Medical , Ltd.
|
4 |
0 |
2024-11-22 |
|
Eos Imaging
|
4 |
1 |
2025-11-14 |
|
Coreline Soft Co., Ltd.
|
4 |
0 |
2025-03-19 |
|
Neurophet., Inc.
|
4 |
3 |
2026-05-15 |
|
Ceevra, Inc.
|
4 |
1 |
2026-08-25 |
|
Qure.Ai Technologies
|
4 |
0 |
2024-08-16 |
|
Circle Cardiovascular Imaging, Inc.
|
4 |
1 |
2025-10-27 |
|
Mriguidance B.V.
|
4 |
1 |
2026-08-21 |
|
Disior, Ltd.
|
4 |
0 |
2025-09-29 |
|
Peek Health, S.A.
|
4 |
2 |
2025-12-22 |
|
Mighty Oak Medical
|
3 |
2 |
2026-06-11 |
|
SimBioSys, Inc.
|
3 |
0 |
2025-07-08 |
|
Subtle Medical, Inc.
|
3 |
1 |
2026-05-15 |
|
Axial Medical Printing Limited
|
3 |
0 |
2025-09-18 |
|
Dentsply Sirona
|
3 |
2 |
2026-08-21 |
|
Surgical Information Sciences, Inc.
|
3 |
0 |
2024-06-14 |
|
Arterys, Inc.
|
3 |
0 |
2025-09-03 |
|
Curemetrix, Inc.
|
3 |
1 |
2026-07-30 |
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 |
| 0656T |
CPT
|
— |
Medium
|
Automated radiological image processing; emerging Category III code for AI-based radiologic software |
| 70553 |
CPT
|
— |
Medium
|
MR imaging of brain with and without contrast; radiological image analysis |
| 76377 |
CPT
|
— |
Medium
|
Ultrasound guidance for intervention; image-guided procedure with AI analysis |
Pulse
Most recent 510(k) clearances
| Date | K-number | Sponsor | Device |
|---|
| 2026-09-25 |
K260055 |
Siemens Medical Solutions USA, Inc.
|
syngo.CT Brain Quantification |
| 2026-09-22 |
K262390 |
Visiana
|
BoneXpert |
| 2026-09-21 |
K261368 |
Ischemaview, Inc.
|
Rapid Platform (R6.7) |
| 2026-09-16 |
K261623 |
GE Medical Systems Ultrasound and Primary Care Diagnostics
|
EchoPAC Software Only / EchoPAC Plug-in (v211) |
| 2026-09-15 |
K261677 |
Aramis Global AI Consultancies, LLC
|
Artificial Intelligence Renal Assessment (AIRA) Version 1 |
| 2026-09-10 |
K261795 |
Omniscient Neurotechnology Pty, Ltd.
|
Quicktome Software Suite |
| 2026-09-10 |
K260879 |
INVIA, LLC
|
4DM |
| 2026-09-09 |
K251417 |
Argus Cognitive, Inc.
|
ReVISION 2 |
| 2026-09-04 |
K260525 |
MRI2CT, Inc.
|
NextMR Spine |
| 2026-08-26 |
K260811 |
Heartvue.ai, Inc.
|
Heartvue.Proton |
| 2026-08-25 |
K261595 |
Ceevra, Inc.
|
Ceevra Reveal 4 |
| 2026-08-21 |
K262127 |
Dentsply Sirona
|
DS Core CBCT Anatomy |
| 2026-08-21 |
K260584 |
Mriguidance B.V.
|
BoneMRI |
| 2026-08-18 |
K261641 |
AI Planning Logic, Inc.
|
Lower Limb AI (LLAI) |
| 2026-08-10 |
K253794 |
Lucida Medical, Ltd.
|
Prostate Core |
| 2026-08-07 |
K252571 |
Mediaire GmbH
|
mdprostate |
| 2026-08-04 |
K253902 |
3DIEMME SRL
|
RealGUIDE |
| 2026-07-31 |
K253835 |
Hermes Medical Solutions AB
|
Affinity |
| 2026-07-30 |
K260980 |
Curemetrix, Inc.
|
cmAngio® V2.0 |
| 2026-07-29 |
K261210 |
Cleerly, Inc.
|
Cleerly Plaque |
| 2026-07-24 |
K261349 |
Airs Medical, Inc.
|
SwiftMR |
| 2026-07-24 |
K260192 |
ROPCA ApS
|
DIANA |
| 2026-07-23 |
K254096 |
Velmeni, Inc.
|
VELMENI for DENTISTS (V4D) 3D |
| 2026-07-20 |
K261535 |
Hi-D Imaging AG
|
Hi-D Imaging 4TAVR |
| 2026-07-15 |
K260206 |
UPlanner B.V. - Presurgeo
|
SkeletonPlanner |