Identifiers
- 510(k) Number
- K201231 FDA 510(k)
- FDA Product Code
- JAK FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.1750 FDA 510(k)
- Regulation Number
- 892.1750 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Ctxx85 Ct Scanner is a System, X-ray, Tomography, Computed, classified as product code JAK. It is designed to produce images of the head and body by computer reconstruction of x-ray transmission data taken at different angles and planes.
The Ctxx85 Ct Scanner is supplied as a Class II device with Special Controls. It has been cleared by the FDA with the issuance of 510(k) number K201231 on February 2, 2021. The device is intended for use in producing images of the head and body.
Frequently asked questions
What is the CTxx85 CT Scanner used for?
The CTxx85 CT Scanner is used to produce images of the head and body by computer reconstruction of x-ray transmission data taken at different angles and planes.
Is the CTxx85 CT Scanner a single-use or reusable device?
The device description does not specify if the CTxx85 CT Scanner is single-use or reusable, but it is classified as a Class II device with Special Controls.
What is the regulatory status of the CTxx85 CT Scanner?
The CTxx85 CT Scanner has been cleared by the FDA with the issuance of 510(k) number K201231 on February 2, 2021, indicating it is substantially equivalent to a predicate device.
How is the CTxx85 CT Scanner supplied?
The CTxx85 CT Scanner is supplied as a system, including the necessary components for producing images of the head and body.
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: CTXX85 by Analogic Corporation | FDA 510 (k) Summary, K201231 FDA 510(k) - CTxx85 CT Scanner | Analogic Corporation, PDF Analogic Corporation February 2, 2021 Laura Green Regulatory Re ..., CTxx85 CT Scanner 510 (k) K201231 - FDA.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K201231 | Class II | Active |
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Manufacturer
- Manufacturer
- Analogic Corporation
Sources (1)
- FDA 510(k) K201231 24 fields · synced Sep 25, 2026