Identifiers
- 510(k) Number
- K251151 FDA 510(k)
- FDA Product Code
- QAS FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.2080 FDA 510(k)
- Regulation Number
- 892.2080 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Rapid CTA 360 is a radiological computer-assisted triage and notification software. It is designed to assist in the analysis of computed tomography angiography (CTA) images for the detection of suspected vascular abnormalities, supporting radiologists in prioritizing cases requiring urgent review.
The device is supplied as software for use in clinical radiology settings. It is intended for use by qualified healthcare professionals in hospitals or imaging centers. The software is not sterile, not implantable, and does not have MRI safety considerations as it is a software-only device. It is regulated as a Class II medical device under FDA 510(k) clearance (K251151) and is authorized for marketing in the United States.
Frequently asked questions
What is Rapid CTA 360 used for?
Rapid CTA 360 is designed to assist in the analysis of computed tomography angiography (CTA) images for the detection of suspected vascular abnormalities, supporting radiologists in prioritizing cases requiring urgent review.
How is Rapid CTA 360 supplied and who is it intended for?
Rapid CTA 360 is supplied as software for use in clinical radiology settings and is intended for use by qualified healthcare professionals in hospitals or imaging centers.
Is Rapid CTA 360 sterile, implantable, or does it have MRI safety considerations?
Rapid CTA 360 is not sterile, not implantable, and does not have MRI safety considerations because it is a software-only device with no physical components that interact with the patient or magnetic fields.
What regulatory pathway was used for Rapid CTA 360 and what is its classification?
Rapid CTA 360 is regulated as a Class II medical device under FDA 510(k) clearance (K251151), with a traditional clearance type and a decision of substantially equivalent to a predicate device.
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.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K251151 | Class II | Active |
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Manufacturer
- Manufacturer
- Ischemaview
Sources (1)
- FDA 510(k) K251151 24 fields · synced Sep 23, 2026