Identifiers
- 510(k) Number
- K131594 FDA 510(k)
- FDA Product Code
- LLZ FDA 510(k)
- Models / Variants
- Ezdenti-I FDA 510(k)E2 FDA 510(k)Prora View 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 Ezdenti-i E2 Prora View is a Class II X-ray system designed for use in radiology. It functions as an imaging device to capture and process diagnostic X-ray data.
This device has received FDA 510(k) clearance. It is manufactured by Ewoosoft Co., Ltd. and is categorized under the radiology advisory committee.
Frequently asked questions
What is the primary function of the Ezdenti-i E2 Prora View?
The Ezdenti-i E2 Prora View is a Class II X-ray system engineered to function as an imaging device. Its primary purpose is to capture and process diagnostic X-ray data for use in radiology applications.
What is the regulatory status of this imaging system?
This device has received FDA 510(k) clearance under the K131594 submission. It was determined to be substantially equivalent to existing devices within the radiology advisory committee category.
Who is the manufacturer of the Ezdenti-i E2 Prora View?
The device is manufactured by Ewoosoft Co., Ltd., which maintains a contact office located in Houston, Texas.
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: Ewoosoft EzDent-i / E2 / Prora View - allmed.wiki, K202116 FDA 510(k) - EzDent-i/ E2/ Prora View/ Smart M Viewer, Ewoosoft EzDent-i; E2; ProraView - allmed.wiki, K241114 - EzDent-i / E2 / Prora View / Smart M Vi... | FDA 510(k)
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K131594 | Class II | Active |
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Manufacturer
- Manufacturer
- Ewoosoft Co., Ltd.
Sources (1)
- FDA 510(k) K131594 24 fields · synced Sep 25, 2026