What is FDA product code QIH?

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.

Radiology › Image Processing and StorageAutomated Radiological Image Processing Software

Cmangio

Name: cmAngio
Brand: cmAngio

cmAngio is intended to process screening mammograms to aid a qualified interpreting physician in the current manual process of identifying Breast Arterial Calcification (BAC). cmAngio, a…

Registry build 21.09.26

cmAngio is intended to process screening mammograms to aid a qualified interpreting physician in the current manual process of identifying Breast Arterial Calcification (BAC). cmAngio, a proprietary artificial intelligence (AI) based software, is intended to detect, at the study and breast level, the presence or absence of Breast Arterial Calcifications (BAC), an incidental finding in both Full Field Digital Mammogram (FFDM) and Digital Breast Tomosynthesis (DBT) screening mammograms. The device also marks BAC segments on thumbnails of images for localization of BAC. The software is intended to be used by qualified interpreting physicians in parallel with breast screening mammography workflow. The device is not intended for primary interpretation of digital mammography images as used for breast cancer detection and should not be used alone to make any diagnosis and/or treatment decisions. cmAngio is for prescription use only.

8manufacturers in China registered for this device type

2catalogue numbers in this listing

3510(k) clearances naming this product code

Who Else Makes It

Concentrated in Beijing (4), Shanghai (2), Jiangsu (1). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code QIH
Manufacturer	City	Province	Registered as	Device types
Philips Ultrasound (Shanghai) Co., Ltd.	Shanghai	Shanghai	Contract manufacturer	5
GE Medical Systems (China) Co., Ltd.	Wuxi	Jiangsu	Contract manufacturer	57
GE Hangwei Medical Systems Co., Ltd.	Beijing	Beijing	Specification developer	22
GE Healthcare (China) Co., Ltd.	Beijing	Beijing	Specification developer	22
Shanghai United Imaging Healthcare Co., Ltd.	Shanghai	Shanghai	Manufacturer	12
Beijing Infervision Healthcare Medical Technology Co., Ltd.	Beijing	Beijing	Complaint-file establishment	4
Wuhan United Imaging Healthcare Co., Ltd.	Wuhan	Hubei	Manufacturer	4
Keya Medical Technology Co., Ltd.	Beijing	Beijing	Manufacturer	2

Record

Regulatory record for cmAngio
Listed by	Curemetrix, Inc., United States
FDA product code	QIH
Device type	Automated Radiological Image Processing Software
Device class	Class 2
Regulation	21 CFR 892.2050
Establishment	Manufacturer
510(k)	K250754
Record published	2025-05-02
Record revised	2023-12-04 (version 2)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Prescription	Prescription only
Label carries	lot or batch number

Catalogue Numbers

Catalogue numbers for cmAngio
Catalogue number	Size	Status
V1.6		In distribution
V1.0		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Imbio RV/LV	Imbio, LLC	5
VEA Align	EOS imaging	4
Qlab Advanced Quantification Software	Philips Ultrasound LLC	3
uOmnispace	Shanghai United Imaging Healthcare Co., Ltd.	3
Scenium	Siemens Medical Solutions USA, Inc.	3
syngo.MI General	Siemens Medical Solutions USA, Inc.	3
Neosoma Dashboard	Neosoma, Inc.	3
BriefCase-Quantification	Aidoc Medical Ltd.	3
OrthoNext™ Platform System Software	Orthofix SRL	3
MI View&GO	Siemens Medical Solutions USA, Inc.	3
FEops	Feops NV	3
AI-Rad Companion Brain MR	Siemens Healthcare Limited	3

Showing 12 of 147. All products under Automated Radiological Image Processing Software

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K260980	2026-07-30
K250754	2025-04-10
K232367	2023-10-05

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.