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

OptimMRI (V2)

Name: OptimMRI (v2)
Brand: OptimMRI (v2)

OptimMRI is a software application intended to aid qualified medical professionals in processing, visualizing, and interpreting anatomical structures from medical images. The software can…

Registry build 21.09.26

OptimMRI is a software application intended to aid qualified medical professionals in processing, visualizing, and interpreting anatomical structures from medical images. The software can be used to process pre-operative DICOM compatible MR images to generate 3D annotated models of the brain that aid the user in neurosurgical functional planning. The annotated MR images can further be used in conjunction with other clinical methods as an aid in localization of the Subthalamic Nuclei (STN) and Ventral Intermediate Nucleus (VIM) regions of interest.

8manufacturers in China registered for this device type

1catalogue number

2510(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 OptimMRI (v2)
Listed by	Rebrain, France
FDA product code	QIH
Device type	Automated Radiological Image Processing Software
Device class	Class 2
Regulation	21 CFR 892.2050
Establishment	Manufacturer
510(k)	K242054
Record published	2024-10-22

Specifications

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

Catalogue Numbers

Catalogue numbers for OptimMRI (v2)
Catalogue number	Size	Status
v2.0.1		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
K242054	2024-08-12
K230150	2023-07-21

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.