Chrysalis Intelligence · Product Codes · QKB

QKB · Radiological Image Processing Software For Radiation Therapy

Radiology · 48 clearances · 28 unique sponsors

Device class
Class II
Regulation 892.2050
Total clearances
48
2020-02-28 → 2026-08-14
Last 12 months
10
Unique sponsors
28
Definition

What is Radiological Image Processing Software For Radiation Therapy

To provide semi-automatic or fully-automated radiological image processing and analysis tools for radiation therapy. Software implementing artificial intelligence (AI) including nonadaptive machine learning algorithms trained with clinical and/or artificial radiological images. In these devices, the algorithm training images typically impact device performance. AI based radiological image processing software is intended to be used in the workflow of radiation therapy. Adaptive AI algorithms are not within the scope of this product code. Primary radiation dose calculation or plan optimization for treatment planning are not within scope of this product code.
Medical specialty
Radiology
Review panel
RA
Regulation number
892.2050
Implant
N
Life-sustain / support
N
GMP exempt
N
Third-party review
N
Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor Clearances Last 12 mo Most recent
Mim Software, Inc. 7 1 2026-03-27
Radformation, Inc. 6 2 2026-08-14
Manteia Technologies Co., Ltd. 3 2 2026-01-23
Ever Fortune.Ai, Co., Ltd. 3 1 2026-01-28
Vysioneer, Inc. 3 0 2021-12-16
Siemens Healthcare GmbH 2 1 2026-04-10
Siemens Medical Solutions USA, Inc. 2 0 2022-10-14
Therapanacea 2 0 2022-06-17
Taiwan Medical Imaging Co., Ltd. 1 0 2025-05-28
Oncosoft. Co., Ltd. 1 0 2025-02-24
Elekta Solutions AB 1 0 2021-10-25
Quanta Computer, Inc. 1 0 2024-02-13
Ge Medical Systems, LLC 1 0 2023-05-04
Mvision AI OY 1 0 2024-10-18
Therapanacea Sas 1 0 2023-04-19
Medmind Technology Co., Ltd. 1 0 2021-12-15
Quantitative Radiology Solutions, LLC 1 0 2021-04-20
Siemens Medical Solutions U.S.A. 1 0 2024-04-03
Varian Medical Systems 1 1 2026-07-10
Oncosoft. Inc., 1 1 2026-07-02
MVision AI 1 0 2022-05-03
GE Healthcare 1 0 2025-04-01
Xiamen Manteia Technology , Ltd. 1 0 2020-02-28
Deepvoxel, Inc. 1 0 2021-04-02
Coreline Soft Co., Ltd. 1 0 2022-11-10
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.

CodeTypeDescriptionConfidenceRationale
77290 CPT Medium Radiation therapy planning software/imaging; AI-based image processing for treatment planning
77295 CPT Medium 3D radiotherapy planning software, inclusive of image processing
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2026-08-14 K262452 Radformation, Inc. AutoContour (RADAC V6)
2026-07-10 K261306 Varian Medical Systems AI Contouring (VA10A)
2026-07-02 K260528 Oncosoft. Inc., OncoStudio
2026-04-10 K252548 Siemens Healthcare GmbH AI-Rad Companion Organs RT
2026-04-10 K252190 Aitewan Biomedical Technology, Inc. DeepBT Detector-Plus
2026-03-27 K253270 Mim Software, Inc. Contour ProtégéAI+
2026-03-19 K260509 Radformation, Inc. AutoContour (RADAC V5)
2026-01-28 K251306 Ever Fortune.Ai, Co., Ltd. Seg Pro V3 (RT-300)
2026-01-23 K251351 Manteia Technologies Co., Ltd. AccuContour 4.0
2025-12-05 K250780 Manteia Technologies Co., Ltd. ARTAssistant
2025-05-28 K250427 Taiwan Medical Imaging Co., Ltd. TAIMedImg DeepMets
2025-04-01 K242925 GE Healthcare MR Contour DL
2025-03-27 K242745 Siemens Healthcare GmbH AI-Rad Companion Organs RT
2025-02-24 K242994 Oncosoft. Co., Ltd. OncoStudio (OS-01)
2025-02-03 K250035 Mim Software, Inc. Contour ProtégéAI+
2024-12-09 K242729 Radformation, Inc. AutoContour (Model RADAC V4)
2024-10-18 K241490 Mvision AI OY Contour+ (MVision AI Segmentation)
2024-10-09 K241837 Limbus Ai, Inc. Limbus Contour
2024-05-07 K232928 Wisdom Technologies., Inc. DeepContour (V1.0)
2024-04-03 K232899 Siemens Medical Solutions U.S.A. AI-Rad Companion Organs RT
2024-02-13 K231855 Quanta Computer, Inc. QOCA® image Smart RT Contouring System
2023-11-08 K231765 Mim Software, Inc. Contour ProtégéAI
2023-09-25 K231928 Ever Fortune.Ai, Co., Ltd. EFAI RTSUITE CT HCAP-Segmentation System
2023-05-04 K230082 Ge Medical Systems, LLC Auto Segmentation
2023-04-19 K230023 Therapanacea Sas ART-Plan