Identifiers
- 510(k) Number
- K923106 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 Scan Band is a System, X-ray, Tomography, Computed, classified as product code JAK. It is a Class II device with Special Controls.
The Scan Band is supplied by Cook, Inc. and has received FDA 510K authorization. It is listed with the product code JAK and has the k number K923106. The device was cleared on September 11, 1992.
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: K923110 - SCAN BAND | FDA 510 (k) | Cook, Inc., Cook Medical Scan Band - allmed.wiki, SCAN BAND (K923110) — FDA 510(k) | Innolitics, Scan And Cook, Inc. Kissimmee, FL - filing information, Scan And Cook, Inc. Kissimmee, FL - filing information
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K923106 | Class II | Active |
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Manufacturer
- Manufacturer
- Cook, Inc.
Sources (1)
- FDA 510(k) K923106 24 fields · synced Sep 22, 2026