Identifiers
- 510(k) Number
- K200760 FDA 510(k)
- FDA Product Code
- POK FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.2060 FDA 510(k)
- Regulation Number
- 892.2060 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Rapid ASPECTS is computer-assisted diagnostic software for lesions suspicious for cancer. It is designed to assist physicians in the analysis of brain images using automated tools for CT ASPECTS.
The device is supplied as software and is used in radiology settings. It has received FDA 510(k) clearance under K200760 and is classified as a Class II medical device with product code POK.
Frequently asked questions
What is Rapid ASPECTS used for?
Rapid ASPECTS is used to assist physicians in analyzing brain CT images by providing automated tools for calculating the ASPECTS score, which helps evaluate the extent of early ischemic changes in lesions suspicious for cancer or stroke.
How is Rapid ASPECTS supplied and used?
Rapid ASPECTS is supplied as software and is intended for use in radiology settings, where it runs on compatible hardware to process brain CT images and support clinical decision-making through automated image analysis.
Is Rapid ASPECTS a single-use or reusable software tool?
Rapid ASPECTS is reusable software that can be used multiple times across different patient cases, as it is designed for ongoing clinical use in radiology workflows without consumption or degradation per use.
What regulatory clearance does Rapid ASPECTS have?
Rapid ASPECTS has received FDA 510(k) clearance under submission number K200760, which confirms it is substantially equivalent to a legally marketed predicate device and is classified as a Class II medical device.
What is the product code and classification for Rapid ASPECTS?
Rapid ASPECTS is classified under product code POK and is a Class II medical device, as indicated in its FDA 510(k) clearance documentation, placing it in the radiology specialty category for computer-assisted diagnostic software.
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: iSchemaView Rapid Technology Now Installed in More Than 500 Stroke ..., iSchemaView Launches Rapid ANGIO, iSchemaview, Inc. (operating as RapidAI): Products, FDA Status ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K200760 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- iSchemaView, Inc.
Sources (1)
- FDA 510(k) K200760 24 fields · synced Oct 1, 2026