(14 days)
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No
The document describes a standard integrated PET/CT system and does not mention any AI or ML capabilities in its intended use, device description, or specific sections for AI/ML information.
No
The device is described as an imaging system used for diagnosis, evaluation, staging, and follow-up, and not for directly treating or mitigating a disease or condition.
Yes
The intended use explicitly states that the device can assist in the "evaluation, diagnosis, staging, restaging, and follow up of lesions, disease and organ function". Additionally, it states that the device can be used as a "stand-alone head and whole body multislice computed tomography (CT) diagnostic imaging system."
No
The device description explicitly states it is an "integrated multi-slice Computed Tomography and Positron Emission Tomography System," indicating it is a hardware system that performs imaging.
No, the GE Discovery VCT System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- GE Discovery VCT Function: The GE Discovery VCT System is an imaging system. It uses PET and CT technology to create images of the inside of the patient's body. It does not analyze specimens taken from the body.
- Intended Use: The intended use clearly states it's for "imaging the distribution of radiopharmaceuticals in the body" and "localization of emission activity in patient anatomy." This is an in-vivo (within the living body) process, not in-vitro (in glass or outside the living body).
Therefore, based on the provided information and the definition of an IVD, the GE Discovery VCT System is a diagnostic imaging device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The GE Discovery VCT System is intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images.
The Discovery VCT is to be used by trained health care professionals for imaging the distribution of radiopharmaceuticals in the body for the assessment of metabolic (molecular) and physiologic functions. This can assist in the evaluation, diagnosis, staging, restaging, and follow up of lesions, disease and organ function such as (but not limited to) cancer, cardiovascular disease, and brain dysfunction. This device can also assist in radiotherapy planning.
The Discovery VCT can also be used as a stand-alone head and whole body multislice computed tomography (CT) diagnostic imaging system.
Product codes (comma separated list FDA assigned to the subject device)
KPS, JAK
Device Description
The Discovery VCT is an integrated multi-slice Computed Tomography and Positron Emission Tomography Seamers and it uses CT images to correct for non-uniform accenduction of the FET images and tomy. Discovery VCT has capabilities for imaging all emission activity in the patient and can provide inherently registered available I ET tracers and of concreation via an integrated graphical user interface. anatomical and ranetional when as a stand-alone head and whole body multislice CT diagnostic imaging system.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
Positron Emission Tomography (PET), Computed Tomography (CT)
Anatomical Site
head and whole body
Indicated Patient Age Range
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Intended User / Care Setting
trained health care professionals
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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).
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§ 892.1200 Emission computed tomography system.
(a)
Identification. An emission computed tomography system is a device intended to detect the location and distribution of gamma ray- and positron-emitting radionuclides in the body and produce cross-sectional images through computer reconstruction of the data. This generic type of device may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories.(b)
Classification. Class II.
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Image /page/0/Picture/1 description: The image shows a blurry, black and white picture of what appears to be a decorative object. The object has a circular shape with intricate designs and patterns. The image quality is poor, making it difficult to discern the exact details of the object.
Technologies
MAR 1 7 2005
510(k) Summary of Safety and Effectiveness (in accordance to 21 CFR 807.87(h))
Device Name Proprietary Device Name:
GE Discovery VCT System
February 1, 2005
P.O. Box 414
Milwaukee, Wi 53201 Phone: 262-544-3894 FAX: 262-548-4768
Date prepared:
Establishment Name and Registration Number of Submitter GE Healthcare Technologies Name: (Formerly GE Medical Systems) 2126677 Registration Number: Larry Kroger Corresponding Official: GE Healthcare Technologies
Device Classification Classification Code: Panel Identification: Classification Name:
90 KPS/90 JAK Radiology Emission Computed Tomography System/ Computed Tomography System (Per 21CFR 892.1200 and 21CFR 892.1750) PET/CT Imaging System Class II Product
Common Name: Classification Class:
Reason for 510(k) Submission Modification of a legally marketed device.
Identification of Legally Marketed Equivalent Devices K041543 GE Discovery ST System GE Discovery ST System with Alternate Detector Option K042257
Device Description
Device Describetion
The Discovery VCT is an integrated multi-slice Computed Tomography and Positron The Discovery VOT 15 an innes. It uses CT images to correct for non-uniform Emission Tomography Seamers and it uses integrated CT and PET images to localize accenduction of the FET images and tomy. Discovery VCT has capabilities for imaging all emission activity in the patient and can provide inherently registered available I ET tracers and of concreation via an integrated graphical user interface. anatomical and ranetional when as a stand-alone head and whole body multislice CT diagnostic imaging system.
General Electric Company P.O. Box 414
1
Technologies
Image /page/1/Picture/1 description: The image shows a black and white abstract design. The design features a dense cluster of dark marks at the top left, which gradually thins out into a more linear pattern extending towards the upper right. A curved line is present at the bottom right, adding a sense of enclosure or boundary to the composition.
510(k) Summary of Safety and Effectiveness February 1, 2005 Page 2
Description of Change or Modification
The Discovery VCT PET/CT System is the same as the Discovery ST system described in 510/k)s K041543 and K042257 except that the PET system is integrated with a different CT system, the GE LightSpeed VCT system.
Indications for Use of Device
The GE Discovery VCT System is intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images.
The Discovery VCT is to be used by trained health care professionals for imaging the distribution of radiopharmaceuticals in the body for the assessment of metabolic (molecular) and physiologic functions. This can assist in the evaluation, diagnosis, staging, restaging, and follow up of lesions, disease and organ function such as (but not limited to) cancer, cardiovascular disease, and brain dysfunction. This device can also assist in radiotherapy planning.
The Discovery VCT can also be used as a stand-alone head and whole body multislice computed tomography (CT) diagnostic imaging system.
Conclusion
In the opinion of General Electric Medical Systems, the Discovery VCT System is substantially the same in design, materials, energy sources, and technology, and is therefore substantially equivalent in terms of safety and effectiveness to the currently marketed Discovery ST System.
General Electric Company P.O. Box 414 Milwaukee, WI 53201
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized image of an eagle with three wavy lines extending from its body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle image.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 17 2005
Re: K050559
GE Healthcare Technologies % Mr. Tamas Borsai Medical Division Manager, Third Party Review Program TUV Rheinland of North America 12 Commerce Road NEWTOWN CT 06470
Trade/Device Name: GE Discovery VCT System Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: KPS and JAK Dated: March 3, 2005 Received: March 3, 2005
Dear Mr. Borsai:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced we have tevewed your bettler ove (1) }
above and have determined the device is substantially equivalent (for the stated in above and nave decemined the ad predicate devices marketed in interstate commerce prior to the enclosure) to tegally manteled problem. Device Amendments, or to devices that have been May 20, 1770, the onlaominent with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that reclassified in accordation with me ket approval application (PMA). You may, therefore, market the do not require approval of a premants 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 (Premarket If your device is olashilos (500 as the additional controls. Existing major regulations affecting your Apploval), it they be saoject to and regulations, Title 21, Parts 800 to 898. In addition, FDA device can be round announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that I lease be advised that i Driver 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 I cacral statues and regularing but not limited to registration and listing (21 CFR Part 807); labeling Act STEQuirements, modeling practice requirements as set forth in the quality systems (QS) (21 CFR Part 801); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
This letter will allow you to begin marketing your device as described in your Section 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:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). You may obtain other general information on your responsibilities under the Act 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/industry/support/index.html.
Sincercly yours,
Nancy C. Hogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
STATEMENT OF INDICATIONS FOR USE
K050557 510(k) Number (if known): ___________________________________________________________________________________________________________________________________________________
Device Name: GE Discovery VCT System
Indications for Use
The GE Discovery VCT System is intended for head and whole body attenuation The GE Discovery VOT Oystom in internation of PET) imaging and localization of Contected Tostion Enlission Tomography (1) (1) of the orated PET and CT images.
The Discovery VCT is to be used by trained health care professionals for The Discovery VOT is to be assure armaceuticals in the body for the assessment imaging the diothbuttar) and physiologic functions. This can assist in the of metabolic (moleoular) and prystaging, and follow up of lesions, disease and evaluation, diagnosis, blaging, rootaging, and organ function. This device can also assist in radiotherapy planning.
The Discovery VCT can also be used as a stand-alone head and whole body multislice computed tomography (CT) diagnostic imaging system.
(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. Hodson
(Division Sign-Off Division of Reproductive, Al and Radiological Devices 510(k) Number