Digirad System 1 And The Reusuable Image Media
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K852284 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 Digirad System 1 and Reusable Image Media is a medical image management and processing system. It provides capabilities for the review and digital processing of medical images to assist trained practitioners in disease detection, diagnosis, or patient management.
This device is authorized via FDA 510K clearance. It is designed for use in radiology settings to support clinical interpretation and image processing workflows.
Frequently asked questions
What is the primary function of the Digirad System 1?
The Digirad System 1 and Reusable Image Media is designed to provide medical image management and processing capabilities. It assists trained practitioners in the review and digital processing of images to support disease detection, diagnosis, and patient management.
In what clinical environment is this system intended for use?
This device is intended for use in radiology settings. It is specifically designed to support clinical interpretation and image processing workflows within these professional medical environments.
What is the regulatory status of the Digirad System 1?
The Digirad System 1 and Reusable Image Media is authorized via FDA 510K clearance. This indicates that the device has been reviewed and found to be substantially equivalent to other legally marketed devices.
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: Digirad System 1 and The Reusuable Image Media, DIGI RAD CORP. FDA Filings - FDA.report, DIGI RAD CORP. FDA Filings - FDA.report, Digirad Reusable Image Media - allmed.wiki
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K852284 | Class II | Active |
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Manufacturer
- Manufacturer
- Digirad Corp.
Sources (1)
- FDA 510(k) K852284 24 fields · synced Sep 24, 2026