(59 days)
No
The summary describes hardware and software changes to improve scan speed and tube capacity, with no mention of AI or ML algorithms for image processing, analysis, or other functions.
No
The device is described as a software control key and a tube option for a CT system, intended to improve scanning speed and heat capacity. It is used for diagnostic imaging (CT scans), not for treating or preventing diseases or conditions.
Yes
Explanation: The device is a CT scanner, which is an imaging modality used by healthcare professionals to visualize internal body structures for diagnostic purposes. The "Intended Use" states it provides scans, which are then interpreted to diagnose medical conditions.
No
The device description explicitly mentions a "Performix tube," which is a hardware component (a metal-cased tube). While a software control key is also part of the option, the overall device includes hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a CT scanner option that improves scanning speed and tube capacity. This is related to medical imaging, not the examination of specimens derived from the human body for the purpose of providing information for diagnosis, monitoring, or treatment.
- Device Description: The device is described as a software control key and a new tube for a CT system. This aligns with medical imaging equipment, not IVD devices which typically involve reagents, calibrators, controls, and instruments used to analyze biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on laboratory tests.
Therefore, this device falls under the category of medical imaging equipment, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
HiSpeed CT/i with Performix Tube and Warp Scan Option is intended to provide 0.8 second 360-degree helical or axial scans as well as increase the maximum tube heat capacity and provides additional mA settings over our existing system.
Product codes
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Device Description
The option is a software control key for the HiSpeed system that increases the allowable speed (Warp Scan), for single rotation to 0.8 seconds for axial and helical scanning as well as 0.5 second rotation for partial scan. The Performix tube provides an additional tube option for use on the HiSpeed Gantry. It is a metal cased tube that has a heat capacity of 6.3MHU. For HiSpeed CT/i systems the maximum available power increases. The new tube takes advantage of power capabilities of the power distribution unit that is currently provided with the system. The increase in available power will not require a change in hardware.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.
0
Summary of Safety & Effectiveness
Product Identification:
JAN 2 4 1997
HiSpeed CT/i with Performix Tube and Warp Scan Option Name: agers Larry Kroger - Regulatory Program Man Submitting Correspondant: General Electric Medical Systems Manufacturer: 16800 W. Ryerson Road New Berlin, WI 53151
Distributor: Same as Manufacturer
Indications for Use:
HiSpeed CT/i with Performix Tube and Warp Scan Option is intended to provide 0.8 second 360-degree helical or axial scans as well as increase the maximum tube heat capacity and provides additional mA settings over our existing system.
Device Description:
The option is a software control key for the HiSpeed system that increases the allowable speed (Warp Scan), for single rotation to 0.8 seconds for axial and helical scanning as well as 0.5 second rotation for partial scan. The Performix tube provides an additional tube option for use on the HiSpeed Gantry. It is a metal cased tube that has a heat capacity of 6.3MHU. For HiSpeed CT/i systems the maximum available power increases. The new tube takes advantage of power capabilities of the power distribution unit that is currently provided with the system. The increase in available power will not require a change in hardware.
Materials: Materials and construction are equivalent to the HiSpeed CT/i and are compliant with UL 187, IEC 601-1, and 21 CFR Subchapter J
Design: The design of HiSpeed CT/i with Performix Tube and Warp Scan Option differs from the information covered in K940606 (HiSpeed CT/i) by the addition of the Performix tube which allows for the widening of mA specifications as well as the increased scan speed. Tube mounting has been strengthened with the new tube to allow for faster scanning.
Energy Source and Exposure Levels: Maximum available output power varies according to the power distribution unit on existing system (there are two possible PDUs in the installed base). 48 kw allows an mA range of 40 to 400 mA and 53 kW allows mA range from 10 to 440 mA. The Performix tube has a heat capacity of 6.3 million heat units (MHU). All else within the system remains the same as the HiSpeed CT/i K940606.
1
Principals of Operation: Same as HiSpeed CT/i K940606.
Features: The features with this option differ from HiSpeed CT/i K940606 only by the additional range of mA available (10 to 440mA) as well as the faster scan speed, 0.8 sec for full scan rotation axials and helicals instead of 1 sec. Partial scan of 0.5 seconds instead of 0.6 sec.
Accessories: No new accessories with this option, all accessories used are the same as HiSpeed CT/i.
Marketing History:
The HiSpeed CT/i with Performix Tube and Warp Scan Option is substantially equivalent to the currently marketed HiSpeed CT/i (K940606).
Adverse Effects on Health:
Potential electrical, mechanical, and radiation hazards are controlled by compliance with industry standards (UL 187 and IEC 601-1), the Federal performance standard (21 CFR Subchapter J), and appropriate directions and warnings in the labeling.
Conclusions:
The HiSpeed CT/i with Performix Tube and Warp Scan Option adds a tube option and increased speed options that intend to improve the speed and efficiency of CT exams. It is the same basic design as HiSpeed CT/i differing only in the tube used which allows for a broader range of mA selections. All other HiSpeed CT/i features are as submitted in K940606. The HiSpeed CT/i with Performix Tube and Warp Scan Option has no differences with regard to safety or effectiveness from HiSpeed CT/i.