(18 days)
Not Found
No
The document describes a combined PET/CT scanner and its technical specifications, focusing on hardware components and image acquisition capabilities. There is no mention of AI, ML, or any related computational techniques for image analysis or processing.
No.
The device is an imaging system used for diagnosis (determining metabolic and physiologic functions, and producing cross-sectional images), not for treating a condition.
Yes.
The device images and measures the distribution of radiopharmaceuticals to determine metabolic and physiologic functions, and produces cross-sectional images of the body to provide detailed anatomic and metabolic function information, which are all diagnostic purposes.
No
The device description clearly states it is a combined PET and CT scanner system with mechanical and electrical components, indicating it is a hardware device with integrated software.
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 CPS LSO PET/CT HiRez 64 system is an imaging device. It uses injected radiopharmaceuticals and X-rays to create images of the inside of the human body. It measures the distribution of these substances and produces cross-sectional images.
- Lack of Sample Analysis: The description does not mention any analysis of biological samples taken from the patient. The device works by imaging the patient directly.
Therefore, while it is a medical device used for diagnosis, it falls under the category of in vivo imaging rather than in vitro diagnostics.
N/A
Intended Use / Indications for Use
The CPS LSO PET/CT HiRez 64 system is a combined positron emission tomography (PET) and X-ray computed tomography (CT) scanner. The LSO PET/CT scanner is intended to be utilized by appropriately trained health care professionals to 1) image and measure the distribution of injected positron emitting radiopharmaceuticals in humans for the purpose of determining various metabolic (molecular) and physiologic functions within the human body; and 2) to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes* taken at different angles.
The PET and the CT functions of this system can also be used in combination to provide high resolution, noise free CT attenuation correction maps for PET images and, additionally, utilized to produce fused CT and PET images, providing detailed anatomic and metabolic function information in a single image.
(*spiral planes: the axial planes resulted from the continuous rotation of detectors and x-ray tube and the simultaneous translation of the patient.)
Product codes (comma separated list FDA assigned to the subject device)
90 KPS, JAK
Device Description
The CPS LSO PET/CT Hi-Rez 64 system is a combined Positron Emission Tomography and X-Ray Computed Tomography scanner. The system is an addition to the current CPS PET/CT Hi-Rez Family of PET/CT systems and is essentially identical to the commercially available CPS LSO PET / CT Hi-Rez 16 system (K033431) with the exception of a higher resolution CT system -Siemens 64 slice CT (K040665).
The system is designed for whole-body oncology, neurology and cardiology examinations. The PET / CT 64 gantry system consists of a separate PET and CT gantry that retain their independent scanning mechanisms, including mechanical and electrical components. In addition, it provides registration and fusion of high-resolution metabolic and anatomic information from the two major components of the system, the Accel Hi-Rez LSO PET scanner and the Siemens Somatom Sensation 64 CT.
The difference between the current Siemens Sensation 16 used in the commercially available CPS PET/CT systems is the number of slices acquired per rotation. Current PET/CT's are capable of acquiring 16 slices per rotation while the Sensation 64 is capable of acquiring 64 slices per rotation, thus increasing the resolution of the acquired CT scan.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Positron Emission Tomography (PET), X-ray Computed Tomography (CT)
Anatomical Site
Whole-body
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Appropriately trained health care professionals, Prescription Use.
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
OCT 1 - 2004
510(K) SUMMARY
(As required by 21 CFR 807.87(h))
ldentification of Submitter
Submitter:
| M. Alaine Medio, RAC |
|---|
| Senior Regulatory Affairs Specialist |
| CTI Molecular Imaging, Inc. |
| 810 Innovation Drive |
| Knoxville, TN 37932 |
| (865)218-2703 |
| (865)218-3019 |
Telephone Number: Fax Number: Date of Submission:
Identification of the Product
| Device Proprietary Name: | LSO PET/CT HiRez 64 |
|---|---|
| Common Name: | Combination Positron Emission Tomography |
| (PET) and Computed Tomography (CT) System | |
| Classification Name: | Emission Computed Tomography System |
| per 21 CFR 892.1200 |
Marketed Devices to which Equivalence is Claimed
Device LSO PET/CT HiRez 16 Somatom Sensation 64 CT
Manufacturer CTI PET Systems (CPS) Siemens Medical Technologies
Device Description:
The CPS LSO PET/CT Hi-Rez 64 system is a combined Positron Emission Tomography and X-Ray Computed Tomography scanner. The system is an addition to the current CPS PET/CT Hi-Rez Family of PET/CT systems and is essentially identical to the commercially available CPS LSO PET / CT Hi-Rez 16 system (K033431) with the exception of a higher resolution CT system -Siemens 64 slice CT (K040665).
The system is designed for whole-body oncology, neurology and cardiology examinations. The PET / CT 64 gantry system consists of a separate PET and CT gantry that retain their independent scanning mechanisms, including mechanical and electrical components. In addition, it provides registration and fusion of high-resolution metabolic and anatomic information from the two major components of the system, the Accel Hi-Rez LSO PET scanner and the Siemens Somatom Sensation 64 CT.
The difference between the current Sjemens Sensation 16 used in the commercially available CPS PET/CT systems is the number of slices acquired
1
per rotation. Current PET/CT's are capable of acquiring 16 slices per rotation while the Sensation 64 is capable of acquiring 64 slices per rotation, thus increasing the resolution of the acquired CT scan.
Indications for Use:
The CPS LSO PET/CT HiRez 64 system is a combined positron emission tomography (PET) and X-ray computed tomography (CT) scanner. The LSO PET/CT scanner is intended to be utilized by appropriately trained health care professionals to 1) image and measure the distribution of injected positron emitting radiopharmaceuticals in humans for the purpose of determining various metabolic (molecular) and physiologic functions within the human body; and 2) to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes* taken at different anqles.
The PET and the CT functions of this svstem can also be used in combination to provide high resolution, noise free CT attenuation correction maps for PET images and, additionally, utilized to produce fused CT and PET images, providing detailed anatomic and metabolic function information in a single image.
(*spiral planes: the axial planes resulted from the continuous rotation of detectors and x-ray tube and the simultaneous translation of the patient.)
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the circle is an abstract image of a bird-like figure. The bird-like figure is composed of three curved lines that form the body and wings.
OCT 1 - 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. M. Alaine Medio, RAC Senior Regulatory Affairs Specialist CPS Innovations 810 Innovation Drive KNOXVILLE TN 37932
Re: K042467
Trade/Device Name: LSO PET/CT HiRez 64 System 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: September 10, 2004 Received: September 15, 2004
Dear Ms. Medio:
We have reviewed your Section 510(k) premarket notification of intent to market the device vice nave fortowed your between ined 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 r ou may, the eleve, minus 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 the 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.
3
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. Bryden
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 Form
Page / of /
510(k) Number (if known):
LSO PET/CT HiRez 64 system Device Name:
Indications for Use:
The CPS LSO PET/CT HiRez 64 system is a combined position emission tomography The CPS LSO F ETOT TIKEE of Byphy (CT) scanner. The LSO PET/CT scanner is (PE ) and X-ray computed tonography (OT) cannelly care professionals to 1) image and Intended to be unitzed by approphately trained riting radiopharmaceuticals in humans for measure the distinbution of injected position of childecular) and physiologic functions and the purpose of determining vanode moss-sectional images of the body by within the numan bouy, and 2) to produced or over it me same axial plane Computer reconstruction or spiral planes* taken at different angles.
The PET and the CT functions of this system can also be used in combination to provide The PET and the OT Tunctions of this to rection maps for PET images and, nigh resolution, noise free of attendance. Son PET images, providing detailed anatomic and metabolic function information in a single image.
("spiral planes: the axial planes resulted from the continuous rotation of detectors and x-( spiral planoche simultaneous translation of the patient.)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
OR
Nancy C. Brodon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K042467
Prescription Use
(Per 21 CFR 801.109)
Over the Counter Use_
(Optional Format 1-2-96)