(104 days)
Not Found
Not Found
No
The document describes standard PET imaging processes, software for acquisition, reconstruction, and display, and a new transmission scanning method. There is no mention of AI, ML, or related concepts.
No.
The device is used for imaging and measuring metabolic/physiologic functions, which is diagnostic, not therapeutic.
Yes
The "Intended Use / Indications for Use" section states that the device is used "for the purpose of determining various metabolic and physiologic functions within the human body," which is a diagnostic purpose.
No
The device description explicitly states that the software is used "in conjunction with ECAT tomographs" and "controls of the patient handling system, transmission sources and septa associated with the ECAT scanner," indicating it is part of a larger hardware system.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens from the human body. The intended use and device description clearly state that this system is used to image and measure the distribution of radiopharmaceuticals within the human body. It's a system for in vivo imaging, not for testing samples outside the body.
- The process involves injecting a substance into the patient. This is a key characteristic of in vivo imaging techniques like PET, not in vitro diagnostics.
The device is a medical imaging system used for diagnostic purposes, but it operates in vivo, not in vitro.
N/A
Intended Use / Indications for Use
Siemens/CPS ECAT positron emission tomography (PET) scanners are intended to be utilized by appropriately trained health care professionals to image and measure the distribution of injected positron emitting radiopharmaceuticals in humans for the purpose of determining various metabolic and physiologic functions within the human body.
ECAT software is used in conjunction with ECAT tomographs for acquisition, reconstruction, archiving, display and the processing of data acquired from ECAT PET scanners. In addition, the ECAT software controls of the patient handling system, transmission sources and septa associated with the ECAT scanner.
Single photon detection transmission scanning is a proposed alternative to the currently used coincidence detection transmission method for measuring the attenuation effect of the body on the tracer radiation being detected and imaged. Attenuation correction is utilized to enable quantitative interpretation of the acquired emission data.
Product codes
90 KPS
Device Description
Software version 7.1 and Single Photon Detection Transmission Scan System for ECAT PET Scanners
ECAT software is used in conjunction with ECAT tomographs for acquisition, reconstruction, archiving, display and the processing of data acquired from ECAT PET scanners. In addition, the ECAT software controls of the patient handling system, transmission sources and septa associated with the ECAT scanner.
Single photon detection transmission scanning is a proposed alternative to the currently used coincidence detection transmission method.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Positron Emission Tomography (PET)
Anatomical Site
human body
Indicated Patient Age Range
Not Found
Intended User / Care Setting
appropriately 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)
Not Found
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
Image /page/0/Picture/0 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular in shape, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the circle is an abstract symbol that resembles an eagle or a bird in flight. The symbol is composed of three stylized lines that form the head, body, and tail of the bird.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 25 1998
William Skremsky Regulatory Affairs Specialist CTI, Inc. 810 Innovation Drive Knoxville, Tennessee 37932 Re:
K974256 ECAT Pet Scanner System and Software Version 7.1 Dated: January 23, 1998 Received: January 26, 1998 Regulatory class: II 21 CFR 892.1200/Procode: 90 KPS
Dear Mr. Skremsky:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate -commerce prior to May 28, 1976, the eastment date of the Medical Device Americans, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). 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 and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class III (Prematicer Approval), it inay be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Resulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes complisace with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (2) CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning vour device in the Federal Register. Thease note: this response to your premarket notification submission does not affect any obligation you might have under sections 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,
Lillian Yin, Ph.D.
Director, Division of Reproductive, Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and ---Radiological Health
Enclosure
1
Page 1 of 1
510(k) Number (if known): 774256
Device Name: Software version 7.1 and Single Photon Detection Transmission Scan System for ECAT PET Scanners
Indications For Use:
Siemens/CPS ECAT positron emission tomography (PET) scanners are intended to be utilized by appropriately trained health care professionals to image and measure the distribution of injected positron emitting radiopharmaceuticals in humans for the purpose of determining various metabolic and physiologic functions within the human bodv.
ECAT software is used in conjunction with ECAT tomographs for acquisition, reconstruction, archiving, display and the processing of data acquired from ECAT PET scanners. In addition, the ECAT software controls of the patient handling system, transmission sources and septa associated with the ECAT scanner.
Single photon detection transmission scanning is a proposed alternative to the currently used coincidence detection transmission method for measuring the attenuation effect of the body on the tracer radiation being detected and imaged. Attenuation correction is utilized to enable quantifative interpretation of the acquired emission data.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David C. Seymour
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K974256
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)