Shimadzu Whole Body X-Ray Computed Tomography Scanner SCT-6800TXL
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K982583 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)
This device is a whole body X-ray computed tomography scanner designed for diagnostic imaging of the entire body. It produces cross-sectional images using X-ray technology to support clinical evaluation and diagnosis.
It is supplied as a non-sterile, reusable medical device intended for use in radiology settings. The device received traditional 510(k) clearance from the FDA under K982583 and is classified under product code JAK. It is not MRI safe unless explicitly stated, and no sterility, single-use, or size specifications are provided in the data.
Frequently asked questions
What is the Shimadzu SCT-6800TXL used for?
The Shimadzu SCT-6800TXL is a whole body X-ray computed tomography scanner designed to produce cross-sectional images for diagnostic imaging of the entire body, supporting clinical evaluation and diagnosis in radiology settings.
Is the Shimadzu SCT-6800TXL sterile or single-use?
The device is supplied as non-sterile and is intended for reuse; no sterility or single-use specifications are provided in the data, and it is designed for repeated use in radiology environments after appropriate cleaning.
How was the Shimadzu SCT-6800TXL cleared for market?
The Shimadzu SCT-6800TXL received traditional 510(k) clearance from the FDA under submission K982583, with a decision of substantially equivalent, and is classified under product code JAK for radiology devices.
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 | K982583 | Class II | Active |
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Manufacturer
- Manufacturer
- Shimadzu Corp.
Sources (1)
- FDA 510(k) K982583 24 fields · synced Sep 21, 2026