510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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QKBClass II

Radiological Image Processing Software For Radiation Therapy

21 CFR 892.2050 / Radiology
FDA source (opens on fda.gov)

QKB is the FDA product code for Radiological Image Processing Software For Radiation Therapy, a class II device type, regulated under 21 CFR 892.2050. FDA's definition for this code reads: "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...". As of , FDA records hold 49 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
QKB
Device name
Radiological Image Processing Software For Radiation Therapy
FDA definition
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.
Regulation
21 CFR 892.2050
Device class
Class II
Review panel
Radiology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
49
Ingested recalls
0

Clearances, product code QKB

By decision year
49 clearances under product code QKB with a decision year between 2018 and 2026, 2021 the highest year at 9.
Show the numbers
510(k) clearances under FDA product code QKB by decision year
YearClearances
20181
20204
20219
20227
20237
20246
20256
20269

Applicants with the most clearances

Product code QKB
Applicants holding the most 510(k) clearances under product code QKB
ApplicantClearances
MIM Software Inc7
Radformation, Inc.6
Ever Fortune.Ai, Co., Ltd.3
Manteia Technologies Co.,Ltd.3
Siemens Medical Solutions USA, Inc.3
Vysioneer, Inc.3
GE Healthcare2
MVISION AI Oy2
Oncosoft Inc.2
Siemens Healthcare GmbH2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 21 companies shown, in name order