K964583 · Elscint, Inc. · JAK · Jan 17, 1997 · Radiology
Device Facts
Record ID
K964583
Device Name
XRT-7.0
Applicant
Elscint, Inc.
Product Code
JAK · Radiology
Decision Date
Jan 17, 1997
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 892.1750
Device Class
Class 2
Device Story
XRT-7.0 option for CT Twin flash scanners; adds X-ray tube with 7.0 MHU anode heat capacity. Increases convenience by reducing tube cooling delays. Operated by radiology staff in clinical CT imaging environments. Output is X-ray radiation for diagnostic imaging, consistent with predicate CT scanner functionality.
Clinical Evidence
No clinical data; bench testing only. Safety and effectiveness established via mechanical and electrical similarity to predicate.
Technological Characteristics
X-ray tube with 7.0 MHU anode heat capacity. Integrates with existing CT-Twin flash hardware and software drivers.
Regulatory Classification
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.
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JAN 17 1997
K964583
# 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 X-ray 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.
