(14 days)
Not Found
No
The document describes a standard integrated PET/CT scanner and does not mention any AI or ML capabilities in its description, intended use, or technical details.
No.
This device is an imaging system (PET/CT scanner) used for diagnosis, evaluation, and follow-up, not for treating diseases or conditions.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device "can assist in the evaluation, diagnosis, staging, restaging, and follow up of lesions, disease and organ function". It also states that the system "can also be used as a stand-alone head and whole body multi-slice computed tomography (CT) diagnostic imaging system." This clearly indicates its role in diagnosis.
No
The device description clearly states it is an "integrated multi-slice Computed Tomography and Positron Emission Tomography scanner," indicating it is a hardware device with integrated software.
Based on the provided information, the GE Discovery ST system is not an In Vitro Diagnostic (IVD) device.
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 ST system is an imaging device that uses PET and CT technology to visualize the distribution of radiopharmaceuticals within the patient's body. It directly images the patient, not samples taken from the patient.
- Intended Use: The intended use describes imaging the distribution of radiopharmaceuticals and using integrated PET and CT images for localization and assessment of metabolic and physiologic functions. This is an in vivo (within the living body) process, not in vitro (in glass or outside the living body).
Therefore, the GE Discovery ST system falls under the category of medical imaging devices, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The GE Discovery ST 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 ST 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 ST system can also be used as a stand-alone head and whole body multi-slice computed tomography (CT) diagnostic imaging system.
Product codes
KPS, JAK
Device Description
The Discovery ST is an integrated multi-slice Computed Tomography and Positron Emission Tomography scanner. 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 it uses integrated CT and PET images to localize emission activity in the patient anatomy. Discovery ST has capabilities for imaging all available PET tracers and CT contrast agents and can provide inherently registered anatomical and functional information via an integrated user interface. It can also be used as a standalone head and whole body multi-slice computed tomography 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)
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.
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Image /page/0/Picture/0 description: The image shows the text "K041543 Page 1 of 2" in a handwritten style. The text is slightly blurry, suggesting it may be a scan or a photograph of a document. The numbers and letters are written in black ink on a white background.
510(k) Summary of Safety and Effectiveness (in accordance to 21 CFR 807.87(h))
Device Name
Name:
Proprietary Device Name:
GE Discovery ST
Submitter Information:
GE Healthcare
3000 N. Grandview Blvd. Address: Waukesha, WI 53188
2126677 Registration Number:
Contact Information:
Larry A. Kroger, Ph.D. Senior Regulatory Programs Manager
GE Healthcare P.O. Box 414 Milwaukee, WI 53201
(262) 544-3894
Date Prepared:
May 7, 2004
Device Classification
Classification Code: Classification Name: KPS Emission Computed Tomography System (per 21 CFR 892.1200)
and
Classification Code: Classification Name: JAK Computed Tomography X-ray System (per 21 CFR 892.1750)
Panel Identification: Classification Class: Radiology Class II Product
Identification of Legally Marketed Equivalent Devices
Product Name: 510(k) #:
GE Discovery ST K022872
Product Name: 510(k) #:
GE Discovery LS K040172
General Electric Company 3000 N Grandview Blvd Waukesha, WI 53188 U.S.A.
Image /page/0/Picture/30 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined in a stylized, cursive font. The letters are enclosed within a circular border, and there are three small, white, teardrop-shaped elements placed around the circle, one at the top and two at the bottom.
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K041543
Fingerlift2
510(k) Summary of Safety and Effectiveness Page 2
Device Description
The Discovery ST is an integrated multi-slice Computed Tomography and Positron Emission Tomography scanner. 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 it uses integrated CT and PET images to localize emission activity in the patient anatomy. Discovery ST has capabilities for imaging all available PET tracers and CT contrast agents and can provide inherently registered anatomical and functional information via an integrated user interface. It can also be used as a standalone head and whole body multi-slice computed tomography diagnostic imaging system.
Intended Use
The GE Discovery ST 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 ST 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 ST system can also be used as a stand-alone head and whole body multi-slice computed tomography (CT) diagnostic imaging system.
Conclusion
In the opinion of GE Healthcare, the modified GE Discovery ST is substantially equivalent in terms of safety and effectiveness to the currently marketed GE Discovery ST, 510(k) number K022872, and GE Discovery LS, 510(k) number K040172.
Image /page/1/Picture/11 description: The image shows the General Electric (GE) logo. The logo consists of the letters "G" and "E" intertwined in a stylized, cursive font. The letters are white and set against a black circular background, which is then surrounded by a white ring.
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Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is an abstract image of a bird.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 2 2004
GE Healthcare % Mr Tomas Borsai Program Manager TUV Rheinland of North America 12 Commerce Road NEWTOWN CT 06470
Re: K041543
Trade/Device Name: GE Discovery ST 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: 90 KPS and JAK Dated: June 3, 2004 Received: June 8, 2004
Dear Mr. Borsai:
We have reviewed your Section 510(k) premarket notification of intent to market the device w onever and have 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 for associated in the 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 I ou may, its ve 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.
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 many 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.
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Page 2
This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will and you to organ mading of substantial equivalence of your device to a legally promatics notification. The 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 If you desire spoolite ac mone 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 Additionally, 101 questions of (301) 594-4639. Also, please note the regulation entitled, "Misbranding Other of Ochipmanes as (21CFR Part 807.97) you may obtain. Other general by relevence to promative is new less the Act may be obtained from the Division of Small mormation on your roopensional 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. Brydon
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
510(k) Number (if known): K041543
Device Name:
GE Discovery ST
Indications for Use:
The GE Discovery ST system is intended for head and whole body attenuation corrected The GE Discovery ST System is intonography (PET) imaging and localization of emission activity in
Positron Emission Tomography (PET) imaging and IST Position Emission Tomography (1 27) integrated PET and CT images.
The Discovery ST is to be used by trained health care professionals for imaging the The Discovery 31 Is to be assu by frainounce in the assessment of metabolic distribution of radiophamaceations. This can assist in the evaluation, diagnosis,
(molecular) and physiologic functions. This can assist in the evely of the (molecular) and physiologic functions. This can act argan function such as (but not staging, restaging, and follow up of lesions, disease and brain dysfunction. This device can also assist in radiotherapy planning.
The Discovery ST system can also be used as a stand-alone head and whole body The Discovery ST System ocarant.org/CT) diagnostic imaging system.
Prescription Use
(21 CFR 801 Subpart D)
Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David be Symm
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Device 510(k) Number.