(410 days)
TSX-011A
Not Found
No
The description focuses on hardware and software upgrades for faster image reconstruction and display, and enhanced control, without mentioning AI or ML algorithms.
No
The device is described as an upgrade kit for a CT system, intended to speed up and provide enhanced flexibility for interventional procedures, thereby supporting existing CT system clinical uses. This indicates it is a diagnostic imaging device rather than one that treats or cures a disease.
Yes
Computed Tomography X-Ray Scanners are used for imaging, and the device description states it operates as an optional upgrade to a CT system, which is inherently a diagnostic imaging modality. The intended use also mentions speeding up "interventional procedures typically performed on CT," implying its use in clinical settings for diagnostic support.
No
The device description explicitly states the kit consists of both hardware and software components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or treatment.
- This device is a Computed Tomography (CT) X-Ray Scanner upgrade. CT scanners are imaging devices that use X-rays to create cross-sectional images of the body. They directly image the patient, not specimens taken from the patient.
- The intended use describes supporting interventional procedures performed on CT and providing real-time viewing of the scanned area. This is consistent with an imaging device used for guidance and visualization during medical procedures.
Therefore, the function and intended use of this device fall under the category of medical imaging equipment, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
Computed Tomography X-Ray Scanners generally support three modes of imaging:
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Multiple contiguous slices: conventional CT where individual slices of axial data are acquired, with the table advancing a set distance until a volume of interest is covered.
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Helical Scanning: a volume of interest is scanned continuously while the patient table is advanced longitudinally, until a desired volume of data is acquired.
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Dynamic scanning: a single slice location is scanned repeatedly over a period of time.
Using the Real-Time Reconstruction System (RTRS) Option, the scanner effectively operates in the dynamic scan mode with the added flexibility of table and/or gantry movement during scanning. Under the control of the operating physician the RTRS is intended to speed up interventional procedures typically performed on CT. By permitting the operator to view the scanned area in virtual real time the RTRS is intended to support existing CT system clinical uses by offering enhanced operator flexibility coupled with the potential of reduced scan time.
Product codes
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Device Description
The TSXF-001A is an optional upgrade kit available for the Xpress/SX CT system (TSX-011A/50). The kit consists of hardware and software that can be field installed by a qualified Field Service Engineer. When equipped with this option, the Xpress/SX system will have the capability to reconstruct and display axial slices at the rate of six images per second, effectively emulating a real-time display presentation. Additionally, an added control panel provides table-side control of x-ray initiation and termination, table longitudinal and vertical motion, and gantry tilt.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Computed Tomography X-Ray
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
operating physician
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
TSX-011A
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
K45-0472
K56972
510 (k) Summary
| Date: | APR 15 1996
16 February, 1995 | |
|----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|--|
| Submitter: | Javad Seyedzadeh, Director of Regulatory Affairs
Toshiba America Medical Systems, Inc.
2441 Michelle Drive; Tustin, CA 92681-2068 | |
| Contact: | Mark Stauffer, Regulatory Affairs Specialist
(714) 730-5000 | |
| Device Name: | TSXF-001A | |
| Common Name: | Real-Time Reconstruction System Option for Xpress/SX
CT System | |
| Classification Name: | Computed Tomography X-Ray System | |
| Classification: | Class II | |
| Establishment Reg. Number: | 2020563 | |
| Predicate Device: | TSX-011A (Xpress CT System) [Toshiba Corp.] | |
Description of this device: The TSXF-001A is an optional upgrade kit available for the Xpress/SX CT system (TSX-011A/50). The kit consists of hardware and software that can be field installed by a qualified Field Service Engineer. When equipped with this option, the Xpress/SX system will have the capability to reconstruct and display axial slices at the rate of six images per second, effectively emulating a real-time display presentation. Additionally, an added control panel provides table-side control of x-ray initiation and termination, table longitudinal and vertical motion, and gantry tilt.
Intended use of this device: Computed Tomography X-Ray Scanners generally support three modes of imaging:
-
Multiple contiguous slices: conventional CT where individual slices of axial data are acquired, with the table advancing a set distance until a volume of interest is covered.
-
Helical Scanning: a volume of interest is scanned continuously while the patient table is advanced longitudinally, until a desired volume of data is acquired.
-
Dynamic scanning: a single slice location is scanned repeatedly over a period of time.
Using the Real-Time Reconstruction System (RTRS) Option, the scanner effectively operates in the dynamic scan mode with the added flexibility of table and/or gantry movement during scanning. Under the control of the operating physician the RTRS is intended to speed up interventional procedures typically performed on CT. By permitting the operator to view the scanned area in virtual real time the RTRS is intended to support existing CT system clinical uses by offering enhanced
1
operator flexibility coupled with the potential of reduced scan time.
Features included with the RTRS to help control patient radiation dose are:
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Use of an attenuating filter which is moved automatically into the x-ray beam when the RTRS mode is selected.
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Automatic interruption of scanning after a maximum period of one hundred seconds.
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Display of the elapsed scan time on the in-room viewing monitor.
Comparison to predicate device: The Xpress/SX with Real-Time Reconstruction System option is an upgraded version of the predicate, the Xpress CT System. The enhancements of the Xpress/SX with RTRS include a larger x-ray generator, faster reconstruction time, a solid-state x-ray detector, and real-time reconstruction capabilities. Taken together, these features provide user flexibility and improvements to the efficiency with which the system is utilized. There are no perceived or imagined new intended uses for CT introduced by the Xpress/SX with RTRS option and the safety and effectiveness of the system are believed to remain within the accepted boundaries for this modality.