(21 days)
No
The summary describes a combined PET/CT imaging system and its intended use, focusing on image acquisition, attenuation correction, and localization. There is no mention of AI, ML, or related concepts in the device description, intended use, or performance studies. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No.
The device is an imaging system designed for diagnosis, not for treating or preventing disease.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device facilitates "stand alone head and whole body multislice X-ray computed tomography diagnostic imaging." This directly indicates its diagnostic purpose. Additionally, it mentions "facilitating localization of emission activity in the patient anatomy by means of integrated CT and PET images," which is part of the diagnostic process.
No
The device description explicitly states it integrates a GE Positron Emission Tomography system and a GE LightSpeed Ultra CT System, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for imaging (PET and CT) of the patient's head and whole body. This is a diagnostic imaging system, not a device that analyzes samples taken from the body (like blood, urine, or tissue).
- Device Description: The description reinforces that it's an integrated imaging system (PET and CT) used for creating images of the patient's anatomy.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any of the typical components or processes associated with in vitro diagnostics.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device directly images the patient's body.
N/A
Intended Use / Indications for Use
The GE Mobile Discovery ST PET CT Imaging System is intended for use in head and whole body attenuation corrected Positron Emission Tomography (PET) imaging, facilitating localization of emission activity in the patient anatomy by means of integrated CT and PET images, and stand alone head and whole body multislice X-ray computed tomography diagnostic imaging.
Product codes
90-KPS
Device Description
The GE Mobile Discovery ST PET CT Imaging System integrates a GE Positron Emission Tomography system and a GE LightSpeed Ultra CT System. In addition to providing CT and PET stand-alone capabilities, it uses the CT images to correct for non-uniform attenuation of the PET images and to facilitate localization of the emission activity in the patient anatomy. It is designed for use in a mobile van for transportability between diagnostic imaging sites.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Positron Emission Tomography (PET), X-ray Computed Tomography (CT)
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
The device has been evaluated for electrical, and radiation safety, and conforms with applicable medical device safety standards. Clinical Tests: None required.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
FEB 1 1 2003
Attachment B:
Summary of Safety and Effectiveness Prepared in accordance with 21 CFR Part 807.92(c).
GE Medical Systems
General Electric Company P.O. Box 414. Milwaukee. WI 53201
| Submitter: | GE Medical Systems
PO Box 414
Milwaukee, WI 53201 |
|------------------|------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | D. Duersteler
Safety and Regulatory Engineering
Telephone: 262-312-7029; Fax: 262-312-7144 |
| Date Prepared: | January 17, 2003 |
| Device Name: | GE Mobile Discovery ST PET CT Imaging System.
Emission Computed Tomography System, 21 CFR 892.1200, 90-KPS |
| Marketed Device: | GE Medical Systems Discovery ST PET CT Imaging System, 510(k) Number
K022872, currently in commercial distribution. |
Device Description: The GE Mobile Discovery ST PET CT Imaging System integrates a GE Positron Emission Tomography system and a GE LightSpeed Ultra CT System. In addition to providing CT and PET stand-alone capabilities, it uses the CT images to correct for non-uniform attenuation of the PET images and to facilitate localization of the emission activity in the patient anatomy. It is designed for use in a mobile van for transportability between diagnostic imaging sites.
Indications for Use: The GE Mobile Discovery ST PET CT Imaging System is intended for use in head and whole body attenuation corrected Positron Emission Tomography (PET) imaging, facilitating localization of emission activity in the patient anatomy by means of integrated CT and PET images, and stand alone head and whole body multislice X-rav computed tomography diagnostic imaging.
Comparison with Predicate Device: The GE Mobile Discovery ST PET CT Imaging System is of a comparable type and substantially equivalent to the currently marketed GE Discovery ST CT-PET System. It has the same technological characteristics, is comparable in key safety and effectiveness features, uses the same basic design, construction, and materials, and has the same intended uses as the predicate device.
Summary of Studies: The device has been evaluated for electrical, and radiation safety, and conforms with applicable medical device safety standards.
Clinical Tests: None required.
Conclusion: Intended uses and other key features are consistent with traditional clinical practice, FDA quidelines, and established methods of patient examination. Intended uses and fundamental scientific technology are the same as the legally marketed GE Discovery LS CT-PET System. The design and development process of the manufacturer conforms with 21 CFR 820, ISO 9001 and EN 46001 quality systems. The device conforms to applicable medical device safety standards and compliance is verified through independent evaluation with factory surveillance. Therefore, it is the opinion of GE Medical Systems that the GE Mobile Discovery ST PET CT Imaging System is substantially equivalent with respect to safety and effectiveness to devices currently cleared for market.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is an abstract symbol consisting of three stylized human profiles facing right, with flowing lines beneath them.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 1 2003
Mr. David Duersteler Safety and Regulatory Engineer General Electric Company GE Medical Systems P.O. Box 414 MILWAUKEE WI 53201
Re: K030199
Trade/Device Name: GE mobile Discovery ST PET CT Imaging System Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulatory Class: II Product Code: 90 KPS Dated: January 17, 2003 Received: January 21 2003
Dear Mr. Duersteler:
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.
2
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 the 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" (21CFR Part 807.97) you may obtain. 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. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
Page 2
3
Special 510(k) Premarket Notification GE Medical Systems - GE Discovery ST Mobile PET CT System January 17, 2003
STATEMENT OF INTENDED USE
030199 510(k) Number (if known):
Device Name: GE Mobile Discovery ST PET CT Imaging System
Indications for Use
The GE Mobile Discovery ST PET Imaging System is intended for use in head and whole body attenuation corrected Positron Emission Tomography (PET) imaging, facilitating localization of emission activity in the patient anatomy by means of integrated CT and PET images, and stand alone head and whole body multislice X-ray computed tomography diagnostic imaging.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Prescription Use
| (Per 21 CFR 801-109) | |
|---|---|
| ------------------------------------------ | -- |
Concurrence of CDRH, Office of Device Evaluation (ODE)
| OR Over-The-Counter Use | |
|---|---|
| ------------------------- | -- |
David h. Segram
(Division Sian-Off Division of Reproductive. and Radiological Dr 510(k) Number