Device class
Class II
Regulation 892.2050
Total clearances
318
2020-03-25 → 2026-08-10
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.
|
12 |
3 |
2026-06-25 |
|
Dia Imaging Analysis, Ltd.
|
10 |
0 |
2025-03-17 |
|
Shanghai United Imaging Healthcare Co., Ltd.
|
6 |
1 |
2026-04-22 |
|
Clarius Mobile Health Corp.
|
5 |
1 |
2026-03-02 |
|
Overjet, Inc.
|
5 |
2 |
2026-04-10 |
|
Siemens Healthcare GmbH
|
5 |
2 |
2026-04-10 |
|
Ischemaview, Inc.
|
5 |
1 |
2025-09-23 |
|
Aidoc Medical , Ltd.
|
4 |
0 |
2024-11-22 |
|
Qure.Ai Technologies
|
4 |
0 |
2024-08-16 |
|
Circle Cardiovascular Imaging, Inc.
|
4 |
1 |
2025-10-27 |
|
Neurophet., Inc.
|
4 |
3 |
2026-05-15 |
|
Eos Imaging
|
4 |
1 |
2025-11-14 |
|
Coreline Soft Co., Ltd.
|
4 |
0 |
2025-03-19 |
|
Disior, Ltd.
|
4 |
1 |
2025-09-29 |
|
Peek Health, S.A.
|
4 |
2 |
2025-12-22 |
|
DeepHealth, Inc.
|
3 |
1 |
2026-05-21 |
|
Curemetrix, Inc.
|
3 |
1 |
2026-07-30 |
|
Axial Medical Printing Limited
|
3 |
1 |
2025-09-18 |
|
Subtle Medical, Inc.
|
3 |
1 |
2026-05-15 |
|
Arterys, Inc.
|
3 |
1 |
2025-09-03 |
|
Viz. Ai, Inc.
|
3 |
0 |
2025-06-10 |
|
Surgical Information Sciences, Inc.
|
3 |
0 |
2024-06-14 |
|
Mighty Oak Medical
|
3 |
2 |
2026-06-11 |
|
SimBioSys, Inc.
|
3 |
0 |
2025-07-08 |
|
Exo, Inc.
|
3 |
0 |
2024-11-20 |
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 |
|---|
| 2026-08-10 |
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 |
| 2026-07-07 |
K260973 |
Beijing Infervision Healthcare Medical Technology Co., Ltd.
|
InferOperate Suite |
| 2026-06-29 |
K253969 |
Adas3D Medical S.L.
|
ADAS 3D |
| 2026-06-29 |
K253628 |
Agada Medical, Ltd.
|
Auto-Seg (SO-0012), Spine Auto-Seg (SO-0012) |
| 2026-06-25 |
K253786 |
Siemens Medical Solutions USA, Inc.
|
syngo.CT Coronary Cockpit |
| 2026-06-22 |
K260316 |
Cercare Medical A/S
|
CMN Capillary Function with Oncology Virtual Expert |
| 2026-06-18 |
K261713 |
FUJIFILM Healthcare Americas Corporation
|
Synapse PACS (7.6.0) |
| 2026-06-15 |
K260300 |
Anumana, Inc.
|
WatchMate Software |
| 2026-06-15 |
K253690 |
Siemens Healthineers AG
|
LungMaps |
| 2026-06-15 |
K253172 |
Crescom Co., Ltd.
|
MediAI-OA |
| 2026-06-12 |
K260406 |
Brainomix Limited
|
Brainomix 360 Hyperdensity |
| 2026-06-11 |
K260322 |
Mighty Oak Medical
|
Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX) |
| 2026-06-04 |
K260497 |
Keya Medical Technology Co., Ltd.
|
DEEPVESSEL Plaque |
| 2026-05-29 |
K260077 |
OrthoGrid Systems, Inc.
|
OrthoGrid Hip AI® 4.0 |
| 2026-05-28 |
K261405 |
Imeka Solutions, Inc.
|
ANDI 2.2 |