(88 days)
Not Found
No
The summary describes "real time" reconstruction and display, which is a performance characteristic related to processing speed, not necessarily AI/ML. There is no mention of AI, ML, deep learning, or any related concepts in the provided text.
No
This device is an imaging system (x-ray computed tomography scanner) used for diagnostic purposes (imaging during procedures), not for providing therapeutic treatment.
Yes
Explanation: The device is an x-ray computed tomography scanner used to generate images for procedures requiring imaging, which are then observed by a physician. This process of using imaging to visualize internal structures for medical evaluation falls under diagnostic purposes.
No
The device description explicitly states it is an "x-ray computed tomography scanner based on the HiSpeed CT/i platform consisting of a gantry, patient table, console, computer and associated accessories," indicating it includes significant hardware components beyond just software.
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 derived from the human body (like blood, urine, or tissue) outside of the body.
- Device Description: The description confirms it's an "x-ray computed tomography scanner," which is an imaging modality.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any other elements typically associated with in vitro diagnostics.
IVD devices are specifically designed to perform tests on samples taken from the body to provide information about a person's health status. This device is an imaging system used for diagnostic purposes through visualization, which falls under the category of medical imaging devices, not IVDs.
N/A
Intended Use / Indications for Use
The SmartView Option for HiSpeed CT/i is indicated for head and whole body x-ray computed tomography applications. This option is a modifications which can be added to the existing family of HiSpeed CT/i Systems. The option provides almost "real time" reconstruction (SmartView) with a display latency of less than one second. An in-room monitor provides an image display with 6 frame/sec display of up to ninety, one second rotation, scans. Controls are provided for the control of the table and gantry by a physician or their assistant during procedures that require imaging.
Product codes (comma separated list FDA assigned to the subject device)
90 JAK
Device Description
The SmartView Option for HiSpeed CT/i is an x-ray computed tomography scanner based on the HiSpeed CT/i platform consisting of a gantry, patient table, console, computer and associated accessories.
Materials and construction are equivalent to the HiSpeed CT/i and are compliant with UL 187, IEC 601-1, and 21 CFR Subchapter J.
The design is essentially the same as the HiSpeed CT/i (K940606) and CT/i with Performix Tube Option (K964746) the difference being that the SmartView option includes an inroom monitor, a hand control, and a footswitch for initiating x-rays. The hand control allows for gantry tilt and table positioning as well as control of viewing of the scans displayed in the room.
The energy source and exposure levels are the same as those previously submitted for HiSpeed CT/i and HiSpeed CT/i with Performix Tube Option.
The Principals of Operation are the same as HiSpeed CT/i and HiSpeed CT/i with Performix Tube Option.
Mentions image processing
The SmartView Option for HiSpeed CT/i is indicated for head and whole body x-ray computed tomography applications. This option is a modifications which can be added to the existing family of HiSpeed CT/i Systems. The option provides almost "real time" reconstruction (SmartView) with a display latency of less than one second. An in-room monitor provides an image display with 6 frame/sec display of up to ninety, one second rotation, scans. Controls are provided for the control of the table and gantry by a physician or their assistant during procedures that require imaging.
Mentions AI, DNN, or ML
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Input Imaging Modality
x-ray computed tomography
Anatomical Site
head and whole body
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician or their assistant during procedures that require imaging.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
GE Medical Systems
General Electric Company P.O. Box 414, Milwaukee, WI 53201
2 | 1991
Summary of Safety & Effectiveness
This 510(k) summary of Safety and Effectiveness information is submitted in accordance with the requirements of 21 CFR Part 807.87(h)
Larry A. Kroger, Ph.D. Submitter. Regulatory Programs Manager Who may be contacted by telephone at 414-544-3894 or by FAX at 414-544-3863. Summary prepared 21 August 1997
Product Identification Name: SmartView Option for HiSpeed CT/i
Manufacturer. General Electric Medical Systems 16800 W. Rverson Road New Berlin, WI 53151
Same as Manufacturer Distributor:
Marketed Devices:
The SmartView Option for HiSpeed CT/i is of a type and substantially equivalent to currently marketed Computed Tomography X-ray Systems that comply with the same or equivalent standards and have the same intended uses.
Device Description:
The SmartView Option for HiSpeed CT/i is an x-ray computed tomography scanner based on the HiSpeed CT/i platform consisting of a gantry, patient table, console, computer and associated accessories.
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 is essentially the same as the HiSpeed CT/i (K940606) and CT/i with Performix Tube Option (K964746) the difference being that the SmartView option includes an inroom monitor, a hand control, and a footswitch for initiating x-rays. The hand control allows for gantry tilt and table positioning as well as control of viewing of the scans displayed in the room.
Energy Source and Exposure Levels: The energy source and exposure levels are the same as those previously submitted for HiSpeed CT/i and HiSpeed CT/i with Performix Tube Option.
Principals of Operation: The same as HiSpeed CT/i and HiSpeed CT/i with Performix Tube Option.
1
Summary (cont.) SmartView Option
Indications for Use:
The SmartView Option for HiSpeed CT/i is indicated for head and whole body x-ray computed tomography applications. This option is a modifications which can be added to the existing family of HiSpeed CT/i Systems. The option provides almost "real time" reconstruction (SmartView) with a display latency of less than one second. An in-room monitor provides an image display with 6 frame/sec display of up to ninety, one second rotation, scans. Controls are provided for the control of the table and gantry by a physician or their assistant during procedures that require imaging.
Comparison with Predicate:
It is the opinion of GE Medical Systems that the SmartView Option for HiSpeed CT/i is of a comparable type and substantially equivalent to currently marketed head and whole body x-ray computed tomography systems with respect to design, material composition, energy source, and radiation characteristics.
Adverse Effects on Health:
Potential electrical, mechanical and radiation hazards are identified in a hazard analysis and controlled by:
- System evaluation to insure performance to specifications and Federal Regulations. .
- Adherence to Industry and International Standards. (UL and IEC) .
Conclusions:
Use of the SmartView Option for HiSpeed CT/i does not result in any new potential safety risks and performs as well as or better than devices currently on the market.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 1 1997
Larry A. Kroger, Ph.D. Regulatory Affairs Program Manager GE Medical Systems, Inc. P.O. Box 414 Milwaukee, WI 53201
Re:
SmartView Option for HiSpeed CT/i Dated: August 25, 1997 Received: August 25, 1997 Regulatory class: II 21 CFR 892.1750/Procode: 90 JAK
Dear Dr. Kroger:
We have reviewed your Section 510(k) notification of intent to market the device and we have determined the device is substantially equivalent (for the including) to devices marketed in interstate in interstate commerce prior to May 28, 1976, the enactment date of the Medical Devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Fremarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (2) CFR Part 801 and additionally 809.10 for in viro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for question and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours.
h.Liau Yu
Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
K973168 510(k) Number (if known):
Device Name: SmartView Option for HiSpeed CT/i
Indications For Use:
The SmartView Option for HiSpeed CT/i is indicated for head and whole body x-ray computed tomography applications.
The SmartView Option is a "real time" reconstruction with a display latency less than one second. An in-room monitor provides an image display with 6 frame/sec display of ninety, one second rotation, scans. Controls are provided for the control of the table and gantry by a physician or their assistant during procedures that require imaging.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use __ (Per 21 CFR 801-109)
Over-The Counter Use_ OR
Daniel A. Seymore
(Division Sign-Off) Division of Reproductive, bdominal. ENT and Radiological Devic 510(k) Number