(14 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on standard PET/CT technology and image processing for attenuation correction and localization, without mentioning any AI/ML-specific features or algorithms.
No
The device is used for imaging and diagnosis, not for treating or curing diseases. Its functions include evaluation, diagnosis, staging, restaging, and follow-up of lesions, disease, and organ function, as well as assisting in radiotherapy planning, which are all diagnostic or planning functions.
Yes
The text explicitly states that the device can "assist in the evaluation, diagnosis, staging, restaging, and follow up of lesions, disease and organ function" and also that it can be used as a "stand-alone head and whole body multislice computed tomography (CT) diagnostic imaging systems."
No
The device description explicitly states it is an "integrated multi-slice Computed Tomography and Positron Emission Tomography scanner," which are hardware devices.
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 taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device function: The GE Discovery XR and XA Systems are imaging devices (PET/CT scanners). They work by detecting radiation emitted from radiopharmaceuticals administered to the patient in vivo (within the living body) and using X-rays to create anatomical images. They do not analyze samples taken from the body.
- Intended Use: The intended use clearly describes imaging the distribution of radiopharmaceuticals and using CT for anatomical localization and attenuation correction. This is an in vivo imaging process, not an in vitro diagnostic test.
Therefore, the GE Discovery XR and XA Systems fall under the category of medical imaging devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The GE Discovery XR and XA Systems are 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 XR and XA are 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. These devices can also assist in radiotherapy planning.
The Discovery XR and XA can also be used as stand-alone head and whole body multislice computed tomography (CT) diagnostic imaging systems.
Product codes (comma separated list FDA assigned to the subject device)
KPS, JAK
Device Description
The Discovery XR and XA are integrated multi-slice Computed Tomography and Positron Emission Tomography scanners. They use CT images to correct for non-uniform attenuation of the PET images and integrated CT and PET images to localize emission activity in the patient anatomy. Discovery XR and XA have capabilities for imaging all available PET tracers and CT contrast agents and can provide inherently registered anatomical and functional information via an integrated graphical user interface. Discovery XR and XA can also be used as a stand-alone head and whole body multislice CT diagnostic imaging system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Positron Emission Tomography (PET), Computed Tomography (CT)
Anatomical Site
head and whole body
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained health care professionals
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
§ 892.1200 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
JUN 1 2 2008
GE Healthcare
Image /page/0/Picture/2 description: The image shows a logo of the letters 'GE' inside of a circle. The letters are white, and the circle is black. The logo is slightly blurry and pixelated. The logo is likely for General Electric.
510(k) Summary of Safety and Effectiveness lin accordance to 21 CFR 807.87(h))
Device Name Proprietary Device Name:
Discovery XR and XA Diagnostic Imaging Systems April 4, 2008
Date prepared:
Establishment Name and Registration Number of Submitter Name: GE Healthcare
Registration Number: Corresponding Official:
Device Classification Classification Code: Panel Identification: Classification Name:
Common Name: Classification Class: Reason for 510(k) Submission:
3000 N. Grandview Blvd. Waukesha, WI 53188 2126677 D. Duersteler GE Healthcare P.O. Box 414 Milwaukee, WI 53201 Phone: 262-312-7029 262-312-7144 FAX: Email: david.duersteler@med.ge.com
90 KPS/90 JAK Radiology Emission Computed Tomography System/Computed Tomography X-ray System (Per 21CFR 892.1200 and 21CFR 892.1750) PET/CT Imaging System Class II Product Modification to existing device
Device Description
The Discovery XR and XA are integrated multi-slice Computed Tomography and Positron Emission Tomography scanners. They use CT images to correct for non-uniform attenuation of the PET images and integrated CT and PET images to localize emission activity in the patient anatomy. Discovery XR and XA have capabilities for imaging all available PET tracers and CT contrast agents and can provide inherently registered anatomical and functional information via an integrated graphical user interface. Discovery XR and XA can also be used as a stand-alone head and whole body multislice CT diagnostic imaging system.
Identification of Legally Marketed Equivalent Devices
Discovery VCT KO20259 GE Healthcare
General Electric Company P.O. Box 414 Milwaukee, W1 53201
1
Image /page/1/Picture/0 description: The image shows a logo with the letters 'GE' intertwined within a circular border. The logo has a vintage or slightly distressed appearance, with a grainy texture and some imperfections in the lines. The letters 'GE' are stylized and connected, creating a unique and recognizable design.
510(k) Summary of Safety and Effectiveness April 4, 2008 Page 2
Comparison with Predicate Device
The GE Discovery XR and XA Systems are the same as the above predicate device in that they combine a CT and PET scanner system to produce head and whole body attenuation corrected PET images and localization of emission activity in patient anatomy by means of intearated PET and CT images. They employ the same basic major components including integrate PET and CT gontris, patient table, operator console for analysis and display, and a power distribution unit. The fundamental technology of detecting photons emitted from the patient as a result of positron emitting PET tracers creating coincidence events that are detected by a scintillator material and photodetector is the same as the predicate device. The GE Discovery XR and XA differ from the Discovery VCT in the design of the PET gantry subsystem acquisition electronics, an additional reconstruction mode, specific CT models integrated with the system, and improved user interface.
Indications for Use of Device
The GE Discovery XR and XA Systems are 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 XR and XA are 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. These devices can also assist in radiotherapy planning.
The Discovery XR and XA can also be used as stand-alone head and whole body multislice computed tomography (CT) diagnostic imaging systems.
Conclusion
In the opinion of GE Healthcare, the GE Discovery XR and XA Systems are substantially the same in design, materials, energy sources, and technology, do not introduce new safety concerns, perform as well as currently marketed devices, and are therefore substantially equivalent in terms of safety and effectiveness to the currently marketed Discovery VCT System.
General Electric Company P.O. Box 414 Milwaukee, WI 53201
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, with three stylized wing-like shapes above a wavy line.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 12 2008
GE Medical Systems. LLC % Mr. Daniel W. Lehtonen Responsible Third Party Official Intertek Testing Services 2307 E. Aurora Rd., Unit B7 TWINSBURG OH 44087
Re: K081496
Trade/Device Name: Discovery XR and XA Diagnostic Imaging Systems Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulatory Class: II Product Code: KPS Dated: May 28, 2008 Received: May 29, 2008
Dear Mr. Lehtonen:
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 such 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.
3
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.
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 Center for Devices and Radiological Health's (CDRH's) 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 Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrb/industry/support/index.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
4
Indications for Use
KO81496 510(k) Number (if known): Device Name: Discovery XR and XA Diagnostic Imaging Systems
Indications for Use:
The GE Discovery XR and XA Systems are 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 XR and XA are 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. These devices can also assist in radiotherapy planning.
The Discovery XR and XA can also be used as stand-alone head and whole . body multislice computed tomography (CT) diagnostic imaging systems.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
Herbert Renner
(Division Sign-Off) Division of Reproductive, Abdominal a Radiological Devices 510(k) Number