(14 days)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on hardware and basic CT functionality.
No
This device is a CT scanner, which is used for diagnostic imaging, not for treating diseases or conditions.
Yes
The device is a CT scanner system, which is an imaging modality used to produce images for diagnostic purposes. Its intended use for "head and whole body X-ray Computed Tomography applications" directly points to its role in diagnosis.
No
The device description explicitly lists hardware components such as a gantry, patient table, console, and computer, indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "head and whole body X-ray Computed Tomography applications." This describes an imaging device used for diagnostic purposes within the body, not for testing samples outside the body (in vitro).
- Device Description: The description details a CT scanner system, which is a medical imaging device. It does not mention any components or functions related to analyzing biological samples like blood, urine, or tissue.
- Lack of IVD Indicators: There is no mention of analyzing samples, reagents, assays, or any other elements typically associated with in vitro diagnostics.
In summary, the HiSpeed X/i Smart Gantry Option CT Scanner System is a medical imaging device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The HiSpeed X/i Smart Gantry Option CT Scanner System is indicated for head and whole body X-ray Computed Tomography applications.
Product codes
90 JAK
Device Description
The HiSpeed X/i Smart Gantry Option CT Scanner System is composed of a gantry, shared patient table, console, computer, and associated accessories. Materials and construction are equivalent to the HiSpeed Family of CT Systems (K980169) are compliant with UL 2601, IEC 60061-1, and 21CFR Subchapter J. The system is designed to be a head and whole body CT scanner utilizing a solid state detector, an intuitive Operator Console, and the same tube and similar features to the HiSpeed Family of CT Systems (K980169), but now the gantry is on a dolly that travels on rails to provide the capability of scanning by gantry travel instead of cradle travel. The stationary table/cradle to be used is a table that will be shared with a Linear Accelerator. The table/cradle will remain stationary while CT scanning is in progress. No claims related to the table's use outside of CT scanning are being made in this 510(k).
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
Image /page/0/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined within a circular border. The letters are stylized and connected, with the "G" looping around the "E". The border has decorative elements resembling stylized leaves or flourishes.
GE Medical Systems
General Electric Company PO Box 414, Milwaukee, WI 53201
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
This 510(k) summary of Safety and Effectiveness information is submitted in accordance with the requirement of 21 CFR Part 807.87(h).
Larry A. Kroger, Ph.D. Submitter: Senior Regulatory Programs Manager TEL: 262-544-3894, FAX: 262-544-3863 Summary prepared: June 22, 2001
PRODUCT IDENTIFICATION
| Name: | HiSpeed X/i Smart Gantry Option |
|---|---|
| Classification Name: | Computed Tomography X-ray System |
| Manufacturer: | General Electric YMS |
| 7-127 Asahigaoka 4-Chome | |
| Hino-Shi, Tokyo, Japan 191 | |
| Distributor: | General Electric Medical Systems |
| 3000 N. Grandview Blvd. | |
| Waukesha, WI 53188 | |
| Marketed Devices: | The HiSpeed X/i Smart Gantry Option CT Scanner System is of |
| comparable type and substantially equivalent to currently marketed | |
| Computed Tomography X-ray Systems that comply with the same on | |
| equivalent standards and have the same intended uses. |
DEVICE DESCRIPTION
The HiSpeed X/i Smart Gantry Option CT Scanner System is composed of a gantry, shared patient table, console, computer, and associated accessories.
Materials: Materials and construction are equivalent to the HiSpeed Family of CT Systems (K980169) are compliant with UL 2601, IEC 60061-1, and 21CFR Subchapter J.
Design: The system is designed to be a head and whole body CT scanner utilizing a solid state detector, an intuitive Operator Console, and the same tube and similar features to the HiSpeed Family of CT Systems (K980169), but now the gantry is on a dolly that travels on rails to provide
1
the capability of scanning by gantry travel instead of cradle travel. The stationary table/cradle to be used is a table that will be shared with a Linear Accelerator. The table/cradle will remain stationary while CT scanning is in progress. No claims related to the table's use outside of CT scanning are being made in this 510(k).
Indications for Use:
The HiSpeed Xi Smart Gantry Option CT Scanner System is indicated for head and whole body X-ray Computed Tomography applications.
Comparison with Predicate:
It is the opinion of GE Medical Systems that the HiSpeed XI Smart Gantry Option CT Scanner System is of a type and substantially equivalent to currently marketed head and whole body Xray computed topography systems with respect to design, material composition, energy source, and radiation characteristics. It will comply with the X-ray requirements of 21CFR1020.30, 1020.31, and1020.33, as well as the safety requirements of UL2601, IEC 60601 and collateral standards.
Adverse Effects on Health:
Potential electrical, mechanical and radiation hazards are identified in a risk management summary (hazard analysis) and controlled by:
- . System verification and validation to ensure performance to specifications. Federal Regulations, and user requirements.
- . Adherence to industry and international standards. (UL/CSA and IEC).
CONCLUSIONS
The HiSpeed X/i Smart Gantry Option CT Scanner System does not result in any new potential safety risks and performs as well as or better than devices currently on the market. GE considers the HiSpeed X/i Smart Gantry Option CT Scanner System to be equivalent to other marketed devices with the same indications for use and meeting similar standards.
2
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 0 2001
GE Medical Systems, Inc. Mr. Reiner Krumme TUV Rheinland of North America 12 Commerce Road NEWTOWN CT 06470
Re: K012385 HiSpeed X/i Smart Gantry Option Dated: July 24, 2001 Received: July 27, 2001 Regulatory Class: II 21 CFR 892.1750/Procode: 90 JAK
Dear Mr. Krumme:
We have reviewed your Section 510(k) notification of intent to market the device referenced abyest We have reviewed your Section 310(x) noutcation of misen to maked to legally marketed precieated on to televices device is substantially equivalent (10) the matterns tor the Mack in the Madical Device Amendments, or to devices of to devices of to devices of to devices of to devices of t marketed in interstate commerce prior in way 25, 1777, and Chatell Food, Drug, and Cosmetic Act (Act). You may, that have been reclassified in accordance will the provisions of the Act. The general controls provisions of the Act of the therefore, market the device, subject on the general of the reacher of any of the research of the may of the misbranding and adulteration.
If your device is classified (see above) into either class III (Special Controls) or class III (Prematet Approval), it may be subjections If your device is classified (see above) nito ethier class it (optom Control in the Code of Feeder Regulations, to such additional controls. Existing major regulations arecemes compliance with the Current Good Manufacturing Title 21, Parts 800 to 895. A substantally cutration assame Medical Devices: Gencral regulation (21 CFR Part Practice requirements, as set four in the Quality of Son togation (PDA) will verify such assumptions. Fallure 820) and that through periodic QS inspections the Programs in addition, FDA may publish further announcements to comply with the UNP regulation in regulation in regulators to your premarket notification summers on the file file filest was we concerning your device in the Federal Register. Teass now response of your from the Electronic Product arroor any Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) nemarket notification for your fourise and I his letter will allow you to begally 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 (21 CFR Part 801 additionally and to promotion on the promotion on the promotion on the promotion on If you desire specific advice tor your device of Compliance at (301) - Additionally, for questions on the promotion diagnosic devices), please contact the Office of Complance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your entitled, "Misoranting of relevance to premaileri (Strail Manufacturers Assistance at its toll-free number (800) responsibilities under the Act may be octained address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Nancy C Bogdan
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure (s)
3
STATEMENT OF INTENDED USE
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: HiSpeed X/i Smart Gantry Option CT Scanner System
Indications For Use:
The HiSpeed X/i Smart Gantry Option CT Scanner System is indicated for head and whole body X-ray Computed Tomography applications.
(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)
-OR-
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
Nancy C. Knudson