(31 days)
Not Found
No
The description focuses on standard image processing and reconstruction techniques with user-controlled parameters, and there is no mention of AI, ML, or related concepts.
No
The device is a software system for image visualization, reconstruction, and reorientation of PET and PET/CT images, not for treating a condition or disease.
No
The device is described as a software system that allows users to visualize, reconstruct, and reorient PET and PET/CT images. It processes raw data to create 3D tomographic data. While it aids in the interpretation of medical images, its primary function is image processing and visualization, not direct diagnosis. It does not provide automated diagnoses, and its use is limited to qualified healthcare providers, indicating it's a tool for them to use in their diagnostic process, rather than a diagnostic device itself.
Yes
The device is explicitly described as a "software and/or computer system" and a "software application installed on desktop computers," with no mention of proprietary hardware components being part of the device itself. It processes data from existing PET/CT scanners.
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. They are used to provide information for diagnosis, monitoring, or screening.
- ImagenPRO™ Function: The ImagenPRO™ system processes and visualizes imaging data (PET and PET/CT). It does not analyze biological samples taken from the body. Its purpose is to help healthcare professionals interpret medical images.
Therefore, while it's a medical device used in diagnosis, it falls under the category of medical imaging software rather than an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The ImagenPRO™ system is a software and/or computer system that allows the user to visualize raw PET and/or PET/CT data, reconstruct myocardial perfusion PET or PET/CT images and reorient PET and/or PET/CT rcconstructed tomograms.
Product codes (comma separated list FDA assigned to the subject device)
KPS, LLZ
Device Description
ImagenPRO™ is a software application installed on desktop computers which allows physicians and healthcare professionals to inspect, reconstruct and reorient myocardial perfusion PET images. The system processes perfusion and gated PET raw emission and transmission data to create 3D tomographic data. The user can select correction parameters, filter setting, range of reconstruction, and reorientation angles. Use of this system is limited to qualified, licensed healthcare providers (radiologists, nuclear cardiologists or nuclear medicine physicians) trained in the use of nuclear medicine imaging devices.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
PET, PET/CT
Anatomical Site
myocardial (perfusion)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified, licensed healthcare providers (radiologists, nuclear cardiologists or nuclear medicine physicians)
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
MAR 1 7 2005
VII. 510-(k) Summary
This summary of 510(k) safety and effectiveness information is submitted in accordance with 21 CFR 807.92.
General Information:
| A. | Submitted By: | Cardiovascular Imaging Technologies
4320 Wornall Road, Suite 55
Kansas City, MO 64111
Tel: 816-531-2842
Fax: 816-531-0643 |
|----|----------------------|---------------------------------------------------------------------------------------------------------------------------------------|
| | Contact Person: | James A. Case |
| B. | Device Trade Name: | ImagenPRO™™ |
| | Classification Name: | System, Emission Computed Tomography |
| C. | Predicate Devices: | Siemens/CTI Accel -- CPS Innovations - K002584
GE Discovery LS - General Electric - K023988 |
D. Device Description:
ImagenPRO™ is a software application installed on desktop computers which allows physicians and healthcare professionals to inspect, reconstruct and reorient myocardial perfusion PET images. The system processes perfusion and gated PET raw emission and transmission data to create 3D tomographic data. The user can select correction parameters, filter setting, range of reconstruction, and reorientation angles. Use of this system is limited to qualified, licensed healthcare providers (radiologists, nuclear cardiologists or nuclear medicine physicians) trained in the use of nuclear medicine imaging devices.
-
E. Indications for Use:
The ImagenPRO™ system is a software and/or computer system that allows the user to visualize raw PET and/or PET/CT data, reconstruct myocardial perfusion PET or PET/CT images and reorient PET and/or PET/CT rcconstructed tomograms. -
F. Comparison of Technical Characteristics to Predicate Device:
The ImagenPRO™ system and its predicates, the Siemens e.cat and the GE Discovery LS utilize the same type of data sets for analysis and calculation of data.
Page 71 of 99
1
Summary: H.
Testing and comparison of technological characteristics and intended uses found that all resting and companison of won™ system are equivalent to the predicates.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains an abstract image of an eagle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the circle.
Public Health Service
MAR 1 7 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Cardiovascular Imaging Technologies % Ms. Melanie Hasek Sr. Regulatory Affairs Specialist Regulatory/Clinical Consultants, Inc. 200 NE Mulberry LEE'S SUMMIT MO 64086
Re: K050366
Trade/Device Name: ImagenPROTM System Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: KPS and LLZ Dated: February 14, 2005 Received: February 14, 2005
Dear Ms. Hasek:
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 (Premarket Approval), 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 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 (Scctions 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) Fills letter with and in you've organ and cquivalence of your device of your device to a legally prematice nodicate 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 If you desire specific act 100 for your as 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 807.97). You may obtain other general information on your responsibilities under the Act from the 007. 77. " ou may obtain varers, 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/industry/support/index.html.
Sincerely yours,
Nancy C. hogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
I. Indications for Use:
Indications for Use Form
Page 1 of 1
510(k) Number (if known): K150366
Device Name: ImagenPRO™
Indications For Use:
The ImagenPRO™ system is software that allows the user to visualize raw PET and/or The Indigent RO - System is beforeial perfusion PET or PET/CT images and reorient PET and/or PET/CT reconstructed tomograms.
Prescription Use
(Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy C. Broadon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K0503(da