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The StarSpeed Series CT Scanner Systems are indicated for head and whole body X-ray Computed Tomography applications.

The StarSpeed Series CT Scanner Systems are composed of a gantry, patient table, operator console, computer, and PDU and includes image acquisition hardware, image acquisition and reconstruction software, and associated accessories. StarSpeed Series is evolutionary modification to LightSpeed 5.0 (K030420) and incorporates the features, function, and some hardware of our current production LightSpeed 4.0 (K013561)16 slice system, the LightSpeed 3.0 (K002978) 8 slice system, and LightSpeed 2.0 (K000300) 4 slice system.

The StarSpeed Series is designed to be a head and whole body CT scanner incorporating the same basic fundamental operating principles and Indications for Use. Materials and construction are equivalent to our existing marketed products, which are compliant with UL 2601-1. IEC 60061-1 and associated collateral and particular standards, and 21CFR Subchapter J.

The provided text is a 510(k) summary for the GE Healthcare StarSpeed Series CT Scanner Systems. However, it does not contain any information regarding acceptance criteria, device performance metrics, or any specific study detailing such criteria or performance.

The document primarily focuses on establishing substantial equivalence to previously marketed devices (LightSpeed CT Scanners) through evolutionary modifications. It lists the device description, indications for use, comparison with predicate devices, and conclusions regarding safety and equivalence.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, as this information is not present in the provided input. The document is essentially a regulatory filing establishing equivalence, not a detailed performance study report.

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