(82 days)
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and provides no other indication of AI/ML use.
No
The device is an x-ray computed tomography scanner, which is a diagnostic imaging device, not a therapeutic one. It is used to generate images for diagnosis, not to treat conditions.
Yes
Explanation: The device is an x-ray computed tomography scanner used for head and whole-body applications, which are diagnostic imaging procedures in medical facilities.
No
The device description explicitly states it consists of hardware components like a gantry, patient table, console, and computer, in addition to being mounted within a trailer. This indicates it is a physical medical device with integrated software, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "head and whole body x-ray computed tomography applications". This describes an imaging device used to visualize internal structures of the body, not a device used to examine specimens (like blood, urine, or tissue) outside of the body to diagnose diseases or conditions.
- Device Description: The description details the components of an x-ray CT scanner, which is an imaging modality.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any other typical components or processes associated with in vitro diagnostics.
In summary, the Mobile CT ProSpeed is an in vivo diagnostic imaging device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Mobile CT ProSpeed is indicated for head and whole body x-ray computed tomography applications to be mounted in a trailer. The Mobile CT ProSpeed has the same indications for use as the CT ProSpect Plus (formerly known as CT Sytec 8000 K913485) and CT ProSpeed Family with HiLight Detector K944013.
Product codes
Not Found
Device Description
The device is an x-ray computed tomography scanner consisting of a gantry, patient table, console, computer, and associated accessories, mounted within a trailer.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
x-ray computed tomography
Anatomical Site
head and whole body
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:
Name: Mobile CT ProSpeed
| Manufacturer: | GE - Yokogawa Medical Systems
7-127 Asahigaoka, Hino-shi
4-chome, Tokyo 191, Japan | Distributor: | GE Medical Systems
3000 N. Grandview
Waukesha, WI 53188 | K963896 |
|---------------|------------------------------------------------------------------------------------------|--------------|---------------------------------------------------------------|---------|
| Mobile Coach: | Calumet Coach Co.
2150 Dolton Ave. | | | |
Indications for Use:
The Mobile CT ProSpeed is indicated for head and whole body x-ray computed tomography applications to be mounted in a trailer. The Mobile CT ProSpeed has the same indications for use as the CT ProSpect Plus (formerly known as CT Sytec 8000 K913485) and CT ProSpeed Family with HiLight Detector K944013.
Calumet City, IL 60409
Device Description:
The device is an x-ray computed tomography scanner consisting of a gantry, patient table, console, computer, and associated accessories, mounted within a trailer.
Materials: Materials and construction are equivalent to the CT ProSpeed Plus and are CT ProSpeed Family with HiLight Detector which are compliant with UL 187, IEC 601-1, and 21 CFR Subchapter J.
Design: The design is essentially the same as the CT ProSpeed with larger mounting bolts for the table and gantry as well as special instructions for the set-up and take down of the system.
Energy Source and Exposure Levels: The energy source is the same as the CT ProSpeed Plus and CT ProSpeed Family with HiLight Detector with the same x-ray tube and generator.
Principals of Operation: The same as the CT ProSpeed Plus and CT ProSpeed Family with HiLight Detector.
Features: The same as the CT ProSpeed Plus and CT ProSpeed Family with HiLight Detector.
Accessories: The same accessories as the CT ProSpeed Plus and CT ProSpeed Family with HiLight Detector.
Marketing History:
The CT Mobile ProSpeed is substantially equivalent to the currently marketed CT ProSpeed Plus,(K913485) and CT ProSpeed Family with HiLight Detector (K944013).
Adverse Effects on Health:
Potential electrical, mechanical and radiation hazards are controlled by compliance with industry standards (UL 187 & IEC 601-1), the Federal performance standard (21CFR Subchapter )), and warnings in the labeling.
Conclusions:
The CT Mobile ProSpeed is intended to provide a CT scanner capable of being transported between or shared with other medical facilities to help reduce health care costs and provide CT services to areas where they might not otherwise have them. It is substantially equivalent to the CT ProSpeed Plus and in design, CI ProSpeed Family with HiLight Detector construction, energy source, exposure level, principle of operation, features, and accessories.