iMagic V2.0
by Ashva Technologies, Pvt., Ltd. 510(k)
Active
510(k) K071602
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK071602 | Date23 Jul 2007 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- LLZ
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.2050
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The iMagic V2.0 is a radiology image management software system designed for processing and organizing diagnostic imaging data. It facilitates the generation, storage, and retrieval of ultrasound and other radiologic scan reports, supporting efficient workflows in clinical settings. As classified under 21 CFR §892.2050, it functions as a digital tool for picture archiving and communication (PAC) within radiology departments.
This software is intended for use in radiology departments to manage and archive imaging studies, including ultrasound scans. Supplied as a standalone application, it requires installation on a compatible computing system and does not require sterilization or single-use considerations. The device holds FDA 510(k) clearance (K071602) under the Traditional review pathway, with no specified MRI safety classification or size variations. Storage and operational requirements are detailed in the manufacturer’s installation guidelines.
Other devices from Ashva Technologies, Pvt., Ltd.
Questions
AI-generated answers, 1 Oct 2026
What is the iMagic V2.0 software designed to do in a radiology department?
The iMagic V2.0 is a radiology image management system specifically engineered to process, store, and retrieve diagnostic imaging data, including ultrasound scans. It functions as a digital Picture Archiving and Communication (PAC) system, helping radiology departments organize and archive imaging studies for faster access and improved workflow efficiency. This reduces manual handling of reports and enhances collaboration among clinicians.
How is the iMagic V2.0 supplied and does it require sterilization?
The iMagic V2.0 is supplied as a standalone software application that must be installed on a compatible computing system. Unlike physical medical devices, it does not require sterilization or single-use considerations. Installation instructions and system requirements are provided by the manufacturer to ensure proper setup and functionality.
Is the iMagic V2.0 software single-use or reusable?
The iMagic V2.0 is a reusable software solution designed for continuous use within radiology departments. Since it operates on a computing system, it can be utilized repeatedly for managing and archiving imaging studies without any restrictions on usage cycles. The software’s license allows for ongoing deployment across multiple users and studies.
Does the iMagic V2.0 come in different sizes or models?
The iMagic V2.0 is available as a single, unified software version without specified size variations or multiple model references. Its functionality is standardized for processing ultrasound and other radiologic scans, making it a versatile tool for radiology departments regardless of their specific imaging volume or workflow needs.
What storage and operational requirements does the iMagic V2.0 have?
The iMagic V2.0 requires installation on a compatible computing system with sufficient storage capacity to handle imaging data. Detailed storage and operational specifications, including hardware compatibility and system requirements, are outlined in the manufacturer’s installation guidelines. These guidelines ensure optimal performance and integration within existing radiology department infrastructure.