Clever One

Clever One is a dental imaging software designed to acquire, process, view, edit, and analyze medical images for supporting diagnostic and preoperative planning purposes. It supports…

Registry build 21.09.26

Clever One is a dental imaging software designed to acquire, process, view, edit, and analyze medical images for supporting diagnostic and preoperative planning purposes. It supports standard DICOM formats for 2D and 3D image files and enables advanced imaging functionalities for enhanced diagnostic accuracy. The software provides a range of features, including: – 2D Imaging: Loading, editing, and viewing 2D dental images in standard formats (e.g., DICOM, JPG, BMP). – 3D Imaging: Visualization and reconstruction of 3D CT images, including multi-planar views (MPR) and volume rendering. – Preoperative Planning: Implant position simulation, canal drawing, and bone density analysis to support treatment planning. – Data Interoperability: Facilitates data transfer and storage using DICOM-compliant workflows, ensuring compatibility with third-party systems and imaging devices. The software interfaces with dental imaging equipment, such as CT, panoramic, cephalometric, and intraoral X-ray systems, as well as intraoral cameras, for image acquisition. It is designed for use in network environments, allowing users to upload and download clinical diagnostic images and patient data for enhanced collaboration and efficient patient management.

8manufacturers in China registered for this device type
1catalogue number

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 Clever One
Listed by Ewoo Soft Co., Ltd.
FDA product code QIH
Device type Automated Radiological Image Processing Software
Device class Class 2
Regulation 21 CFR 892.2050
510(k) K250005
Record published 2025-05-28

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 Clever One
Catalogue number Size Status
1.0 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
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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

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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer