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510(k) Data Aggregation
(153 days)
This device is intended to be used in the examination of the whole body. / This device is used optionally in CT Fluoroscopy. / This device is operated and used by Physicians and X-ray technologist. / The object of this device is total patient populations. As mentioned at "Intended Use" in this clearance letter, the intended use of the SCT-7000TX W/FLUORO OPTION is the same as that of predicate device SCT-7000TX (K955255) except optional CT fluoroscopy . Consequently, the indications for use of the SCT-7000TX W/FLUORO OPTION are also the same as that of the SCT-7000TX (K955255) except optional CT fluoroscopy
SCT-7000TX X-ray CT Scanner with Fluoro Option
The provided documents are correspondence from the FDA regarding a 510(k) clearance for the Shimadzu SCT-7000TX X-ray CT Scanner with Fluoro Option (K984156), and an "Indications For Use" statement.
These documents do not contain information about acceptance criteria or a study proving that a device meets acceptance criteria. They are administrative documents related to regulatory clearance based on substantial equivalence to a predicate device.
Therefore, I cannot provide the requested information.
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(73 days)
· This device is intended to be used in X-ray CT scanning on whole body.
· This device is operated and used by Physicians and X-ray technologist.
· The object of this device is total patient population.
As mentioned at " Intended Use " in this clearance letter, the intended use of the SCT-6800TXL is as same as that of predicate device SCT- 7000TX ( K955255) and there is no additional indication.
Not Found
This is a 510(k) premarket notification letter from the FDA regarding an X-ray CT scanner. This document does not describe acceptance criteria or a study proving that a device meets acceptance criteria. It is a regulatory approval document confirming substantial equivalence to a predicate device.
Therefore, I cannot extract the requested information from the provided text.
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(34 days)
The SCT-6800TX is an X-ray CT scanner intended for examinations of the whole body. It is equipped with a slipring , and can perform the spiral CT scanning besides conventional scanning. The SCT-6800TX is basically similar in design , composition and function to the SCT-7000TX ( K955255 ) . Therefore, the intended use of the SCT-6800TX is the same as that of the predicate device SCT-7000TX(K955255).
The SCT-6800TX is an X-ray CT scanner intended for examinations of the whole body. It is equipped with a slipring , and can perform the spiral CT scanning besides conventional scanning. The SCT-6800TX is basically similar in design , composition and function to the SCT-7000TX ( K955255 ) .
The provided documents are a 510(k) clearance letter and a portion of a 510(k) submission for the Shimadzu Whole Body X-Ray Computed Tomography Scanner SCT-6800TX. These documents do not contain any information regarding acceptance criteria, study details, performance metrics, sample sizes, ground truth establishment, or expert involvement as requested in the prompt.
The 510(k) clearance process focuses on demonstrating substantial equivalence to a predicate device, not necessarily on presenting new clinical performance studies with detailed acceptance criteria of the kind typically seen for AI/ML-driven devices or novel diagnostic tools.
Therefore, I cannot provide the requested information based on the given input.
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