Identifiers
- 510(k) Number
- K192040 FDA 510(k)
- FDA Product Code
- LLZ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.2050 FDA 510(k)
- Regulation Number
- 892.2050 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The AVIEW Modeler is a three-dimensional (3D) modeling software designed for creating detailed 3D reconstructions from medical imaging data, enabling applications such as 3D printing and anatomical visualization. It facilitates precise spatial modeling to support surgical planning, educational demonstrations, and custom medical device fabrication by converting volumetric imaging into usable 3D formats.
This software is supplied as a digital product, intended for use in radiology and medical research settings where 3D imaging analysis is required. It operates on standard computing platforms and does not require sterilization or physical handling, aligning with regulatory submissions under the FDA’s 510(k) pathway (K192040) and EU Medical Device Regulations (MDR). No specific sterility or single-use/reusable classification applies, as it is a non-physical, software-based solution.
Frequently asked questions
What types of medical imaging data can the AVIEW Modeler process to create 3D reconstructions?
The AVIEW Modeler is designed to work with volumetric medical imaging data, such as CT (computed tomography) or MRI (magnetic resonance imaging) scans, to generate detailed 3D reconstructions. These reconstructions are useful for applications like surgical planning, educational demonstrations, and custom medical device fabrication by converting the imaging data into usable 3D formats.
Is the AVIEW Modeler intended for use in specific clinical settings, and if so, which ones?
The AVIEW Modeler is intended for use in radiology departments and medical research settings where 3D imaging analysis is required. Its primary purpose is to support workflows that rely on precise spatial modeling derived from medical imaging data, such as pre-surgical planning or anatomical visualization.
How is the AVIEW Modeler supplied, and does it require any special handling or storage conditions?
The AVIEW Modeler is supplied exclusively as a digital product, meaning it does not require physical handling, sterilization, or specialized storage. Since it is software-based, it operates on standard computing platforms and can be installed on compatible devices without additional environmental controls.
What regulatory pathways does the AVIEW Modeler follow, and how does that affect its use?
The AVIEW Modeler follows the FDA’s 510(k) pathway (K192040) and is compliant with EU Medical Device Regulations (MDR). This means its regulatory status has been evaluated for substantial equivalence to a predicate device under FDA guidelines and meets the necessary requirements for market authorization in the EU. Clinicians and buyers should confirm local regulatory compliance before use.
Can the AVIEW Modeler be used for custom medical device fabrication, and if so, how does it support that process?
Yes, the AVIEW Modeler supports custom medical device fabrication by converting volumetric imaging data into precise 3D formats. These reconstructions can be exported for 3D printing or other manufacturing processes, enabling the creation of patient-specific devices or anatomical models tailored to individual cases.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: All aview Software - Coreline Soft, Coreline Soft (KOSDAQ:384470) Company Profile & Description, About Coreline Soft | Advancing Radiology with AI, Coreline Soft Co., Ltd. — MedIndexer | MedIndexer
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K192040 | Class II | Active |
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Manufacturer
- Manufacturer
- Coreline Soft Co., Ltd.
Sources (2)
- FDA 510(k) K192040 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced Jun 4, 2026