QIHClass II

Automated Radiological Image Processing Software

21 CFR 892.2050 / Radiology

QIH is the FDA product code for Automated Radiological Image Processing Software, a class II device type, regulated under 21 CFR 892.2050. FDA's definition for this code reads: "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...". As of 2026-09-10, FDA records hold 325 510(k) clearances under this code, the most recent dated 2026-08-26, and 2 recalls.

Classification record

Product code: QIH
Device name: Automated Radiological Image Processing Software
FDA definition: 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.
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: 334
Ingested recalls: 2

Clearances, product code QIH

By decision year

334 clearances under product code QIH with a decision year between 2019 and 2026, 2025 the highest year at 94.

Show the numbers

510(k) clearances under FDA product code QIH by decision year
Year	Clearances
2019	2
2020	11
2021	19
2022	25
2023	45
2024	64
2025	94
2026	74

Applicants with the most clearances

Product code QIH

Applicants holding the most 510(k) clearances under product code QIH
Applicant	Clearances
Siemens Medical Solutions USA, Inc.	13
Dia Imaging Analysis, Ltd.	10
Shanghai United Imaging Healthcare Co., Ltd.	6
Clarius Mobile Health Corp	5
Ischemaview, Inc.	5
Overjet	5
Siemens Healthcare GmbH	5
Aidoc Medical Ltd.	4
Circle Cardiovascular Imaging Inc	4
Coreline Soft Co., Ltd.	4

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 213 companies shown, in name order