Identifiers
- 510(k) Number
- K083649 FDA 510(k)
- FDA Product Code
- KPS FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.1200 FDA 510(k)
- Regulation Number
- 892.1200 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Cardius 3 X-ACT is a gamma camera for Single Photon Emission Computed Tomography (SPECT) integrated with an attenuation device consisting of an x-ray generator. The system is intended for use in the generation of images for nuclear cardiology.
The device is supplied as a system and is intended for single-use. It is not specified as reusable. The device is not described as being MRI safe. The device is regulated under the United States FDA 510(k) program.
Frequently asked questions
What is the Cardius 3 X-ACT used for?
The Cardius 3 X-ACT is a gamma camera for Single Photon Emission Computed Tomography (SPECT) integrated with an x-ray generator. It is intended for generating images for nuclear cardiology.
Is the Cardius 3 X-ACT reusable?
The device is supplied as a system and is intended for single-use. It is not specified as reusable.
How is the Cardius 3 X-ACT regulated?
The device is regulated under the United States FDA 510(k) program.
Is the Cardius 3 X-ACT MRI safe?
The device is not described as being MRI safe.
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: PDF Cardius X-ACT - Digirad, CARDIUS 3 X-ACT by DIGIRAD CORP. | FDA 510 (k) Summary, Digirad Cardius 3 XACT | OVIS Imaging Solutions, K083649 FDA 510 (k) - CARDIUS 3 X-ACT | Digirad Corp.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K083649 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Digirad Corp.
Sources (1)
- FDA 510(k) K083649 24 fields · synced Oct 1, 2026