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

Cycle Clarity

Name: Cycle Clarity
Brand: Cycle Clarity

Follicle Clarity is a cloud-based software application package (Software as a Medical Device, SaMD). It is designed to view and quantify image data acquired on compatible diagnostic…

Registry build 21.09.26

Follicle Clarity is a cloud-based software application package (Software as a Medical Device, SaMD). It is designed to view and quantify image data acquired on compatible diagnostic ultrasound systems. The software functions as an aid to interpreting clinicians by calculating the number and size of hypoechoic structures (ovarian follicles) in a transvaginal ultrasound volume sweep of the ovaries.

8manufacturers in China registered for this device type

1catalogue number

1510(k) clearance

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 Cycle Clarity
Listed by	Cycle Clarity, United States
FDA product code	QIH
Device type	Automated Radiological Image Processing Software
Device class	Class 2
Regulation	21 CFR 892.2050
Establishment	Complaint-file establishment, Manufacturer
510(k)	K212012
Record published	2026-05-21

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Supplied sterile	Yes

Catalogue Numbers

Catalogue numbers for Cycle Clarity
Catalogue number	Size	Status
6.11.02		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
K212012	2022-01-19

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.