(49 days)
Not Found
No
The document describes a standard medical imaging device (EBT Scanner) and its functionalities, focusing on image acquisition, reconstruction, and visualization. There is no mention of AI, ML, or any related technologies in the intended use, device description, or other sections. The functionalities described are typical for a CT scanner of that era.
No
This device is a diagnostic imaging system, designed to produce images for aid in diagnosis, not to provide treatment or therapy.
Yes
The device is explicitly stated as being intended "to function as a diagnostic x-ray system" and aiding "in the diagnosis of lung pathology". It also produces images for "radiologic visualization" and determines "specific quantitative information" for diagnostic purposes.
No
The device description explicitly lists multiple hardware components including a Gantry/Front End Assembly, Rear Electrical/Mechanical Assembly, Patient Table, Operator Console, Computer, HV Power Supply, and water chiller.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases or other conditions.
- Device Function: The GE Imatron e-Speed EBT Scanner System is an imaging device that uses X-rays to produce cross-sectional images of the human anatomy. It works by transmitting X-rays through the body and detecting the attenuation of those X-rays. This is an in vivo (within the living body) diagnostic method, not in vitro.
- Intended Use: The intended uses described all involve imaging the internal structures of the body directly, not analyzing samples taken from the body.
- Device Description: The components listed (Gantry, Patient Table, X-ray source, etc.) are typical of an imaging system, not an IVD.
The device is clearly described as a diagnostic X-ray system and a whole body CT scanner, which are categories of medical devices distinct from IVDs.
N/A
Intended Use / Indications for Use
The intended use of the proposed GE Imatron e-Speed EBT Scanner System remains unchanged from the intended uses of prior predicate Imatron devices and other scanners. The e-Speed is designed - as are all predicate devices - to produce cross sectional images of the entire human anatomy.
Specifically, the e-Speed is intended:
- to permit radiologic visualization of the heart, blood vessels, or lymphatic system, during or after injection of a contrast medium;
- to function as a diagnostic x-ray system to produce two and three dimensional images of the heart, blood vessels, or lymphatic system from a volume of computer reconstructed cross-sectional images from x-ray transmission data from the same axial plane taken at different angles;
- to permit the data from certain three dimensional images to also be presented in time-sequenced or cine fashion;
- to permit the data from three dimensional images to be viewed from a point of view moving inside the tissue, called "fly-through" mode for colons, blood vessels, or airways;
- to be used for clinical situations requiring determination of specific quantitative information, such as the determination of calcium or other materials in bone, tumors, or organs;
- to be used by the physician as an aid in the diagnosis of lung pathology;
- for real-time motion studies, vascular and tissue blood flow analysis, and full three-dimensional volume imaging.
The e-Speed will make use of previously cleared workstation software products and software applications.
Finally, such system is intended to be used in a manner consistent with those devices already classified and set forth in 21 CFR Sections 892.1600 and 892.1750.
Product codes
90 JAK
Device Description
The e-Speed EBT Scanner System ("e-Speed") is composed of a Gantry/Front End Assembly, Rear Electrical/Mechanical Assembly with Electron Source, Patient Table, Operator Console, Computer, HV Power Supply and Power Conditioning and Distribution System, water chiller, and associated accessories.
Materials: Materials and construction are equivalent to the C150XP EBT Scanner System (K001550) and are compliant with UL2601-1, IEC 60601-1, and 21CFR Subchapter J.
Design: The system is designed to be an angiographic X-ray system, and a whole body CT scanner utilizing electron beam technology, a modernized beam control system and redesigned x-ray data acquisition system, a higher power HV supply, an operator console, and the capability to scan at 0.050 sec as the primary mode of operation.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
entire human anatomy, heart, blood vessels, lymphatic system, colons, airways, bone, tumors, organs, lung
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physician
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/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "G" and "E" intertwined within a circle. The letters and the circle are white, and the background is black.
GE Imatron
General Flectric Compan 89 Ovster Point Boulevarr h San Francisco CA 941 367-6545, 650 583-9964 A GE Medical Systems Company
Ko22794
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).
Submitter:
Kerry A. Spear Regulatory and Compliance Manager, GE Imatron TEL: 650-742-8801 FAX: 650-827-7790 Summary prepared: 19 July 2002
PRODUCT IDENTIFICATION
| Name: | e-Speed Electron Beam Tomography (EBT) Scanner System |
|---|---|
| Classification Name: | Angiographic X-ray System |
| Computed Tomography X-ray System | |
| Manufacturer: | GE Imatron |
| 389 Oyster Point Boulevard | |
| South San Francisco, CA 94080 | |
| Distributor: | Same as Manufacturer |
| Marketed Devices: | The e-Speed EBT Scanner System is of comparable type and |
| is substantially equivalent to currently marketed EBT and | |
| Computed Tomography X-ray Systems that comply with the | |
| same or equivalent standards and have the same intended | |
| uses. |
DEVICE DESCRIPTION
The e-Speed EBT Scanner System ("e-Speed") is composed of a Gantry/Front End Assembly, Rear Electrical/Mechanical Assembly with Electron Source, Patient Table, Operator Console, Computer, HV Power Supply and Power Conditioning and Distribution System, water chiller, and associated accessories.
Materials: Materials and construction are equivalent to the C150XP EBT Scanner System (K001550) and are compliant with UL2601-1, IEC 60601-1, and 21CFR Subchapter J.
1
Design: The system is designed to be an angiographic X-ray system, and a whole body CT scanner utilizing electron beam technology, a modernized beam control system and redesigned x-ray data acquisition system, a higher power HV supply, an operator console, and the capability to scan at 0.050 sec as the primary mode of operation.
Indications for Use:
The intended use of the proposed GE Imatron e-Speed EBT Scanner System remains unchanged from the intended uses of prior predicate Imatron devices and other scanners. The e-Speed is designed -- as are all predicate devices -- to produce cross sectional images of the entire human anatomy.
Specifically, the e-Speed is intended:
- to permit radiologic visualization of the heart, blood vessels, or lymphatic 1. system, during or after injection of a contrast medium;
-
- to function as a diagnostic x-ray system to produce two and three dimensional images of the heart, blood vessels, or lymphatic system from a volume of computer reconstructed cross-sectional images from x-ray transmission data from the same axial plane taken at different angles;
- to permit the data from certain three dimensional images to also be presented in 3. time-sequenced or cine fashion;
-
- to permit the data from three dimensional images to be viewed from a point of view moving inside the tissue, called "fly-through" mode for colons, blood vessels, or airways;
- to be used for clinical situations requiring determination of specific quantitative న్. information, such as the determination of calcium or other materials in bone, tumors, or organs;
-
- to be used by the physician as an aid in the diagnosis of lung pathology;
-
- for real-time motion studies, vascular and tissue blood flow analysis, and full three-dimensional volume imaging.
The e-Speed will make use of previously cleared workstation software products and software applications.
Finally, such system is intended to be used in a manner consistent with those devices already classified and set forth in 21 CFR Sections 892.1600 and 892.1750.
2
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Comparison with Predicate:
It is the opinion of GE Imatron that the e-Speed EBT Scanner System is of a type and substantially equivalent to currently marketed angiographic and whole body X-ray computed tomography systems with respect to design, material composition, energy source, and radiation characteristics. It will comply with the X-ray safety requirements of 21CFR 1020.30, 1020.31, and 1020.33, as well as the safety requirements of UL2601-1, IEC 60601-1 and applicable collateral and particular 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 e-Speed EBT 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 Imatron considers the e-Speed EBT Scanner System to be equivalent to other marketed devices with the same indications for use and meeting similar standards.
3
Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services (HHS). The seal features a stylized eagle with three lines representing its body and wings. The eagle faces left and is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES" in a circular arrangement.
Food and Drug Administration 0 Corporate Boulevard Rockville MD 20850
OCT 1 1 2002
General Electric Imatron % Mr. Nishith Desai Primary Third Party Reviewer TÜV Rheinland of North America, Inc. 12 Commerce Road NEWTOWN CT 06470
Re: K022794
Trade/Device Name: e-speed Electron Beam Tomography (EBT) Scanner System Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: 90 JAK
Dated: September 27, 2002 Received: September 27, 2002
Dear Mr. Desai:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, 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 (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.
4
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 (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Nancy C. Snogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
STATEMENT OF INTENDED USE
510(K) Number (if known): K022794_____________________________________________________________________________________________________________________________________
Device Name: e-Speed EBT Scanner System
Indications for Use:
The intended use of the proposed GE Imatron e-Speed EBT Scanner System remains unchanged from the intended uses of prior predicate Imatron devices and other scanners. The e-Speed is designed - as are all predicate devices - to produce cross sectional images of the entire human anatomy.
Specifically, the e-Speed is intended:
- to permit radiologic visualization of the heart, blood vessels, or lymphatic 1. system, during or after injection of a contrast medium;
-
- to function as a diagnostic x-ray system to produce two and three dimensional images of the heart, blood vessels, or lymphatic system from a volume of computer reconstructed cross-sectional images from x-ray transmission data from the same axial plane taken at different angles;
-
- to permit the data from certain three dimensional images to also be presented in time-sequenced or cine fashion;
(Continued on following page)
Concurrence of CDRH, Office of Device Evaluation (ODE)
- OR -
Daniel A. Seymore
(Division Sign-Off) Division of Reproductive. Abdo and Radiological Devices 510(k) Number
Prescription Use (Per 21 CFR 801.109)
Over-The-Counter Use
6
- to permit the data from three dimensional images to be viewed from a point of 4. view moving inside the tissue, called "fly-through" mode for colons, blood vessels, or airways;
- to be used for clinical situations requiring determination of specific quantitative information, such as the determination of calcium or other materials in bone, tumors, or organs;
న్.
- to be used by the physician as an aid in the diagnosis of lung pathology; 6.
- for real-time motion studies, vascular and tissue blood flow analysis, and full 7. three-dimensional volume imaging.
The e-Speed will make use of previously cleared workstation software products and software applications.
Finally, such system is intended to be used in a manner consistent with those devices already classified and set forth in 21 CFR Sections 892.1600 and 892.1750.
Daniel A. Heyman