(63 days)
No
The summary describes a hardware modification (adding an X-ray tube) to an existing CT device and does not mention any software or algorithmic changes related to AI or ML.
No
The device description indicates it is an option added to a CT scanner, specifically an X-ray tube, which is used for imaging and diagnosis, not for therapy.
No
The device description indicates that the XRT-7.0 option adds an X-ray tube to a CT scanner, which is an imaging device used for generating images, not for interpreting or analyzing them to diagnose a condition. The "Intended Use / Indications for Use" is not found, and there are no mentions of image processing, AI, or performance studies that would suggest a diagnostic function beyond image acquisition.
No
The device description explicitly states the addition of an X-ray tube, which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- No mention of in vitro testing: The description focuses on an X-ray tube for a CT scanner, which is an in vivo imaging device. There is no indication of it being used to test samples outside of the body (in vitro).
- Focus on imaging hardware: The description details a component (X-ray tube) for a medical imaging system (CT scanner). IVDs are typically reagents, instruments, or systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae.
- Predicate device is a CT scanner: The predicate device is a CT scanner, which is an imaging device, not an IVD.
Therefore, the XRT-7.0 option for the CT Twin flash is a component of a medical imaging device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Not Found
Product codes
Not Found
Device Description
XRT-7.0 option was added to CT Twin flash. The option adds an Xray tube with 7.0 MHU anode heat capacity to the options list.
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
JAN 17. 1967
Summary of Safety and Effectiveness
1. Device Name
XRT-7.0 option for CT scanners.
2. Submitter
Elscint Inc., 505 Main Str. Hackensack, NJ 07601.
3. New Features Description
XRT-7.0 option was added to CT Twin flash. The option adds an Xray tube with 7.0 MHU anode heat capacity to the options list.
4. Predicate Device
CT-Twin flash submitted in "HRSW Option for CT-Twin Flash", K945512.
5. Safety
The safety of the device is equivalent to the safety of the predicate device, CT Twin flash.
The 7.0 MHU tube option is mechanically and electrically very similar to the previous X-ray tubes and the software driver is the same.
6. Effectiveness
The effectiveness of the device was not significantly changed in respect to the predicate device. CT Twin flash: The increased heat capacity is more convenient to use due to shorter delays for tube cooling.
7. Substantial Equivalency Statement
Based on the above considerations, it is Elscint's opinion that CT scanners with the added XRT-7.0 option is substantially equivalent in safety and effectiveness to its predicate device, CT-Twin flash submitted in "HRSW Option for CT-Twin Flash", K945512.