(106 days)
Not Found
No
The provided 510(k) summary does not mention AI, ML, deep neural networks (DNN), or any related concepts in the device description, intended use, or other sections. The focus is on the hardware and basic imaging capabilities.
No.
The device is used for imaging and diagnosis, not for treating diseases or conditions.
Yes
The "Intended Use / Indications for Use" section explicitly states that the system can "assist in the evaluation, diagnosis, staging, restaging, and follow up of lesions, disease and organ function" including cancer, cardiovascular disease, and brain dysfunction. It also mentions that it can be used as a "stand-alone head and whole body multi-slice computed tomography (CT) diagnostic imaging systems."
No
The device description clearly outlines a physical PET/CT scanner system with hardware components like a gantry, detector rings, and a patient table. It is not solely software.
Based on the provided information, the GE Discovery IQ PET/CT system is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body.
- Device Function: The GE Discovery IQ PET/CT system is an imaging device. It uses PET and CT technology to create images of the inside of the patient's body. This is an in vivo (within the living body) process.
- 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 about visualizing processes within the body, not analyzing samples taken from the body.
Therefore, the GE Discovery IQ PET/CT system falls under the category of medical imaging devices, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
GE Discovery IQ PET/CT 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 system 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 in patients of all ages. This can assist in the evaluation, diagnosis, staging, restaging, and follow up of lesions, disease and organ function such as (but not not limited to) cancer, cardiovascular disease, and brain dysfunction. This device can also assist in radiotherapy planning.
The system can also be used as a stand-alone head and whole body multi-slice computed tomography (CT) diagnostic imaging systems.
Product codes (comma separated list FDA assigned to the subject device)
KPS
Device Description
The Discovery™ IQ consists of a fully integrated 3D Positron Emission Tomography and multi-slice Computed Tomography scanner with all available CT diagnostic applications, except gantry tilt. The PET detector is scalable offering 2 through 5 detector rings. Due to the overall length of the PET/CT, the patient table sits on a special base that drives the table between the PET and CT portions of the gantry. The PET/CT table is rated for a patient weight of 227 Kg (500 pounds) and the cradle travels up to 1700mm on standard systems, or up 2 meters on systems with the 2m scan range option.
Mentions image processing
Not Found
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
patients of all ages
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.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
GE Medical Systems LLC % Mr. Huy Doan Regulatory Affairs Director, MICT GE Healthcare 3000 N. Grandview Blvd. WAUKESHA WI 53188
Re: K141477
Trade/Device Name: Discovery IO Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulatory Class: II Product Code: KPS Dated: August 25, 2014 Received: August 26, 2014
Dear Mr. Doan:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
September 18, 2014
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Michael D. O'Hara
for
Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K141477
Device Name
Discovery IQ
Indications for Use (Describe)
GE Discovery IQ PET/CT 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 system 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 in patients of all ages. 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 system can also be used as a stand-alone head and whole body multi-slice computed tomography (CT) diagnostic imaging systems.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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Image /page/3/Picture/1 description: The image shows the General Electric (GE) logo. The logo is a circular emblem with the letters 'GE' intertwined in a stylized script. The emblem has a silver or metallic appearance, with subtle shading that gives it a three-dimensional effect. The background is plain and white, which makes the logo stand out.
510(k) Summary of Safety and Effectiveness (in accordance to 21
CFR 807.87(h))
Device Name Proprietary Device Name: Date prepared:
Discovery IQ June 3, 2014
Establishment Name and Registration Number of Submitter
Name: Registration Number: Corresponding Official:
GE Medical Systems LLC 2126677 David Duersteler GE Healthcare P.O. Box 414 Milwaukee, WI 53201 Phone: 262-312-7029 Email: david.duersteler@med.ge.com
Device Classification Classification Code: Panel Identification: Classification Name:
Common Name: Classification Class: Reason for 510(k) Submission:
90 KPS Radiology Emission Computed Tomography System (Per 21CFR 892.1200) PET/CT Imaging System Class II Product Modified device
Device Description
The Discovery™ IQ consists of a fully integrated 3D Positron Emission Tomography and multi-slice Computed Tomography scanner with all available CT diagnostic applications, except gantry tilt. The PET detector is scalable offering 2 through 5 detector rings. Due to the overall length of the PET/CT, the patient table sits on a special base that drives the table between the PET and CT portions of the gantry. The PET/CT table is rated for a patient weight of 227 Kg (500 pounds) and the cradle travels up to 1700mm on standard systems, or up 2 meters on systems with the 2m scan range option.
Identification of Legally Marketed Equivalent Devices
Discovery PET/CT 710 GE Medical Systems LLC K133657
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Comparison with Predicate Devices
Both systems are PET/CT systems employ the same design, construction, materials, energy source, operating principles, and technology. Further, reconstruction algorithms are identical to existing methods including iterative reconstruction.
Both systems consist of a fully integrated 3D Positron Emission Tomography and multislice Computed Tomography scanner with all available CT diagnostic applications, except gantry tilt. Due to the overall length of the PET/CT, the patient tables sit on a special base that drives the table between the PET and CT portions of the gantry. The PET/CT table is rated for a patient weight of 227 Kg (500 pounds) and the cradle travels up to 1700mm on standard systems, or up 2 meters on systems with the 2m scan range option.
Both systems are compliant with the same IEC, NEMA and related safety and performance standards.
Both systems use the same acquisition methods and attenuation correction methods. All major functions and features have been previously marketed, and intended uses are the same. Discovery IQ performs as well as currently marketed devices no significant change in safety or effectiveness as compared to the predicate devices, and is therefore substantially equivalent in terms of safety and effectiveness to the currently marketed GE Healthcare Discovery PET/CT 710 product.
Indications for Use of Device
GE PET/CT 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 systems 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 in patients of all ages. This can assist in the evaluation, diagnosis, staging, and follow up of lesions, disease and orqan function such as (but not limited to) cancer, cardiovascular disease, and brain dysfunction. These devices can also assist in radiotherapy planning.
The systems can also be used as a stand-alone head and whole body multi-slice computed tomography (CT) diagnostic imaging systems.
Conclusion
In the opinion of General Electric Medical Systems, the GE Discovery IQ system is substantially the same in design, materials, energy sources, and technology, does not introduce new safety concerns, performs as well as currently marketed devices, and is therefore substantially equivalent in terms of safety and effectiveness to the currently marketed Discovery PET/CT 710 device. (K133657).
General Electric Company P.O. Box 414 Milwaukee, WI 53201