(87 days)
Not Found
No
The summary describes image processing and registration techniques but does not mention AI, ML, or related terms, nor does it provide details about training or test sets typically associated with AI/ML development.
No
The device primarily aids in image processing for attenuation correction and registration of medical images (CT and PET) but does not directly diagnose, treat, or prevent disease. Its output serves as "a secondary data set to assist the physicians read the original PET images," rather than providing a therapeutic function itself.
No
The device processes existing imaging data (PET and CT) to create secondary data sets for attenuation correction and image registration. It does not directly acquire physiological signals or body images for diagnostic purposes, but rather assists physicians in reading original PET images, implying a supportive rather than primary diagnostic role.
Yes
The device is explicitly described as a "software on GE Advantage Windows workstation computers" and a "software application installed on GE Advantage Windows workstation computers." It performs image processing functions and does not mention any associated hardware components that are part of the device itself.
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 ACQA system processes medical images (CT and PET) that are acquired from the patient's body. It does not analyze samples taken from the body.
- Intended Use: The intended use describes image processing and registration for attenuation correction and assisting physicians in reading images. This is a function related to medical imaging interpretation, not laboratory testing of biological samples.
Therefore, the ACQA system falls under the category of medical imaging software, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The ACQA system is a software on GE Advantage Windows workstation computers that allow the user to create averaged CT images for attenuation correction of the whole body or myocardial perfusion PET images, and to register CT images with myocardial perfusion PET images, and save registered CT images for attenuation correction of myocardial perfusion PET images. The PET images corrected with the CT images of ACQA are not a replacement of the original PET images, and they serve as a secondary data set to assist the physicians read the original PET images.
Product codes
KPS, JAK
Device Description
ACQA is a software application installed on GE Advantage Windows workstation computers which allows physicians and healthcare professionals (1) to create averaged CT images for attenuation correction of the whole body oncology or myocardial perfusion PET images, and (2) to register the averaged or helical CT images with their corresponding myocardial perfusion PET images, and save the registered CT images for attenuation correction of the myocardial perfusion PET images. 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
CT, PET
Anatomical Site
Whole body, Myocardial
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified, licensed healthcare providers (radiologists, nuclear cardiologists, or nuclear medicine physicians) trained in the use of nuclear medicine imaging devices.
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
The tests with both laboratory and clinical data sets included in the submission passed the requirements and met specifications.
Summary of Performance Studies
The tests with both laboratory and clinical data sets included in the submission passed the requirements and met specifications.
Key Metrics
Not Found
Predicate Device(s)
GE Discovery ST-K041543, GE Advantage 4D option - K032915
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
510(K) Summary as per 21 CFR 807.92(c)
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Image /page/0/Picture/3 description: The image shows the logo for Texas Medical Imaging Consultants (TMIC). The logo consists of the letters "TMIC" in large, bold, sans-serif font. Below the letters, in a smaller font, are the words "TEXAS MEDICAL IMAGING CONSULTANTS."
General Information:
| A. Submitted by: | Texas Medical Imaging Consultants |
|---|---|
| 4027 Underwood St. | |
| Houston, TX 77025 | |
| Tel: 713-409-3801 |
Tinsu Pan Contact Person:
Date Summary Prepared: 8/25/2011
- Device Trade Name: ACQA B.
Classification Code: KPS
System, Emission Computed Tomography (per 21 CFR 892 1200) Classification Name: Accessory to Emission Computed Tomography System
-
C. Predicate Devices:
GE Healthcare Technologies (formerly GE Medical Systems) - GE Discovery ST-K041543 GE Medical Systems -- Advantage 4D option - K032915 -
D. Device Description:
ACQA is a software application installed on GE Advantage Windows workstation computers which allows physicians and healthcare professionals (1) to create averaged CT images for attenuation correction of the whole body oncology or myocardial perfusion PET images, and (2) to register the averaged or helical CT images with their corresponding myocardial perfusion PET images, and save the registered CT images for attenuation correction of the myocardial perfusion PET images. 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. -
Intended Use of the Device: ﻧﻨ
The ACQA system is a software on GE Advantage Windows workstation computers that allow the user to create averaged CT images for attenuation correction of the whole body or myocardial perfusion PET images, and to register CT images with myocardial perfusion PET images, and save registered CT images for attenuation correction of the myocardial perfusion PET images. The PET images corrected with the CT images of ACQA are not a replacement of the original PET images, and they serve as a secondary data set to assist the physician read the original PET images. -
F. Comparison of Technical Characteristics to Predicate Device:
The ACQA system and its predicates, the GE DST (K041543) and the GE Advantage 4D-option (K032915) utilize the same type of data sets for analysis and data processing. The ACQA, applicable to all GE PET/CT scanners, accomplishes the tasks of registration of CT and PET, and calculation of averaged CT. The same function of ACQA is only supported on the GE PET/CT
1
Image /page/1/Picture/1 description: The image shows the logo for TMIC, which stands for Texas Medical Imaging Consultants. The logo is in black and white, with the letters "TMIC" in large, bold font. Below the letters, the words "TEXAS MEDICAL IMAGING CONSULTANTS" are written in a smaller font. The logo is simple and professional, and it is likely used to represent the company on its website, marketing materials, and other communications.
scanners with Dimension console, and the Advantage 4D option. A summary of differences is provided in the following table.
| Functionality | GE Discovery ST | GE Advantage 4D option | ACQA |
|---|---|---|---|
| 1. Attenuation correction of | |||
| PET data with averaged CT | |||
| data |
- Registration of CT and
PET data | 1. Calculation of averaged
CT data with the VarianTM
respiratory gating
hardware | 1. Attenuation correction
of PET data with averaged
CT data - Registration of CT and
PET data - No VarianTM respiratory
gating hardware is
needed. |
| Applicable PET/CTs | GE PET/CT with Dimension
console | All GE PET/CT scanners | All GE PET/CT scanners |
| Advantages over ACQA | Both data processing and
data correction can be
performed on the
Dimension console | Can produce 10 phases of
4DCT images for Radiation
Oncology application | Data processing on the GE
Advantage Windows
workstation, and
attenuation correction of
PET data on the PET/CT
console. |
| ACQA Advantages over
GE predicate devices | No averaged CT data is
produced. The user can
perform either attenuation
correction by averaged CT
data or registration of
regular CT with PET data,
and cannot use both
options. | Can produce averaged CT
data. However, 4DCT
option is typically installed
for radiation oncology,
not for cardiology. | ACQA is the only software
that does not require the
Dimension console or
4DCT option (installation
of both costs > $200k.) to
compute averaged CT data
for attenuation correction
of the PET data and
registration of the PET
data with either averaged
CT or helical CT data. |
| Large installed base of
Advantage Windows
workstation | Over 10,000 Advantage Windows workstations have been installed worldwide. It is
very likely that a clinic/hospital which wants to use the ACQA software is already with
an Advantage Windows workstation. In this case, ACQA software can be installed
without any addition of hardware. | | |
- G. Performance data: The tests with both laboratory and clinical data sets included in the submission passed the requirements and met specifications.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The text is in all caps and appears to be in a sans-serif font. The logo is black and white.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Mr. Tinsu Pan Chief Technology Officer Texas Medical Imaging Consultants 4027 Underwood Street HOUSTON TX 77025
Re: K113086
Trade/Device Name: ACQA System Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulatory Class: II Product Code: KPS & JAK Dated: October 12, 2011 Received: October 18, 2011
Dear Mr. Pan:
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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of
JAN 1 3 2012
3
medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely Yours,
Mary S Patel
Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
い。
『
The ACQA system is a software on GE Advantage Windows workstation computers that allow the user to create averaged CT images for attenuation correction of the whole body or myocardial perfusion PET images, and to register CT images with myocardial perfusion PET images, and save registered CT images for attenuation correction of myocardial perfusion PET images. The PET images corrected with the CT images of ACQA are not a replacement of the original PET images, and they serve as a secondary data set to assist the physicians read the original PET images.
Mary Pastel
ation and Safety Office of In
510K K113086