(70 days)
Cardiocam K011611
Not Found
No
The document describes a standard cardiac imaging system and its components, with no mention of AI, ML, or related concepts in the intended use, device description, or other sections. The focus is on image acquisition and processing, which is typical for such devices and does not inherently imply AI/ML.
No
The device is described as a "diagnostic imaging device" designed to acquire data for "cardiac multislice images" and produce images representing the "internal distribution of radioactivity in the body." Its purpose is to aid in diagnosis, not to treat a condition.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The system is intended for use as a diagnostic imaging device."
No
The device description explicitly states it is a "compact, dual-head dedicated cardiac camera system comprised of a gantry supporting a fixed 90 degree dual head detector and a patient table," indicating it includes significant hardware components beyond just 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. They are used outside of the body.
- Device Function: The C-Quest system is described as a "diagnostic imaging device" that acquires data for cardiac multislice images. It produces images representing the internal distribution of radioactivity in the body.
- Modality: The input imaging modality is "Emission computed tomography," which is an in vivo imaging technique (performed on a living organism).
- Anatomical Site: It focuses on "Cardiac applications" and other parts of the body, indicating it's used directly on the patient.
The device's function and how it interacts with the patient clearly place it in the category of an in vivo diagnostic imaging device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The C-Quest system is a dual head system designed to acquire data for cardiac multislice images. The system is intended for use as a diagnostic imaging device. When used with the appropriate radio pharmaceuticals, images are produced representing the internal distribution of radioactivity in the body. The system allows you to acquire data from high resolution three dimensional, static, gated or dynamic images of biochemical and metabolic processes using approved radionuclides within the energy range of 60 – 170 keV such as Tc-99m or TI-201.
Product codes (comma separated list FDA assigned to the subject device)
KPS
Device Description
A compact, dual-head dedicated cardiac camera system comprised of a gantry supporting a fixed 90 degree dual head detector and a patient table. The C-Quest system is operated through interaction with an acquisition and processing computer system (NuQuest) or dedicated handheld controller or touch screen.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cardiac applications, chest region and body extremities
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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.
Cardiocam K011611
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
KC 823-81
Submitter: MEDX
C-Quest Premarket Notification: Traditional 510(k)
510(k) Summary
NOV 1 4 2008
| Submitter Name: | MEDX, Inc. |
|---|---|
| Submitter Address: | 3456 N. Ridge Avenue, Suite 100 |
| Arlington Heights, IL 60004 | |
| Establishment Reg. #: | 1419459 |
| Phone Number: | 847.463.2020 |
| Fax Number: | 847.463.2019 |
| Contact Person: | Eric Ellingson |
| Date Prepared: | 02 September 2008 |
| Device Trade Name: | C-Quest System |
| Common Name | Cardiac Gamma Camera System |
| Classification Name, | Emission Computed Tomography System |
| Number & | |
| Product Code: | 892.1200 |
| KPS | |
| Predicate Devices: | Cardiocam |
| Device Description | |
| and Statement of | |
| Intended Use | Device Description : A compact, dual-head dedicated cardiac camera |
| system comprised of a gantry supporting a fixed 90 degree dual head | |
| detector and a patient table. The C-Quest system is operated | |
| through interaction with an acquisition and processing computer | |
| system (NuQuest) or dedicated handheld controller or touch screen. | |
| Statement of Intended Use : C-Quest equipped with NuQuest | |
| (hereinafter referred to as C-Quest system) forms an emission | |
| computed tomography system intended to detect the location and | |
| distribution of gamma-ray emission radionuclides in the body and | |
| produce cross-sectional images through computer reconstruction of | |
| the data. C-Quest system is primarily intended for cardiac | |
| applications, however the C-Quest system design also supports | |
| non-cardiac procedures of the patient's chest region and body | |
| extremities | |
| Summary of | |
| Technological | The C-Quest cardiology scintillation camera design comprises an open |
| gantry supporting a fixed 90 degree dual head detector and a patient | |
| table. C-Quest is operated through interaction with an acquisition and |
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| Characteristics | processing computer system (NuQuest), or the C-Quest's dedicated handheld controller or touch screen. The patient table can perform vertical and horizontal (along long axis) motor-driven movement for patient positioning. Tomographic studies can be performed in a circular or elliptical orbit with or without gating. Each detector head consists of a rectangular Nal(TI) crystal, photo-multiplier tubes (PMTs) and the detector electronics. Planar static and dynamic studies can be performed. The C-Quest system supports gamma-ray emission radionuclides within the energy range of 60 - 170 keV. |
|---|---|
| Conclusion | The information discussed above demonstrates that C-Quest system performs as well as the predicate device |
| Declarations | This summary includes only information that is also covered in the body of the 510(k). This summary does not contain any puffery or unsubstantiated labeling claims. This summary does not contain any raw data, i.e., contains only summary data. This summary does not contain any trade secret or confidential commercial information. This summary does not contain any patient identification information |
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:
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Summary of Technical Characteristics
| Feature | C-Quest | Cardiocam
K011611 |
|-------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | | |
| Manufacturer | MEDX | DANISH DIAGNOSTIC DEVELOPMENT
A/S |
| Classification # &
Product Code | KPS
892.1200 Emission computed
tomography system | KPS
892.1200 Emission computed
tomography system |
| Intended Use | The C-Quest system is a dual head
system designed to acquire data for
cardiac multi-slice images. The
system is intended for use as a
diagnostic imaging device. When
used with the appropriate radio
pharmaceuticals, images are
produced representing the internal
distribution of radioactivity in the
body. The system allows you to
acquire data from high resolution
three dimensional, static, gated or
dynamic imaged of biochemical and
metabolic processes using approved
radionuclides within the range of 60
- 170 keV such asTc-99m, TI-201, or
Co-57. | The Cardiocam system is a dual head
system designed to acquire data for
cardiac multi-slice images. The system is
intended for use as a diagnostic imaging
device. When used with the appropriate
radio pharmaceuticals, images are
produced representing the internal
distribution of radioactivity in the body.
The system allows you to acquire data
from high resolution three dimensional,
static, gated or dynamic imaged of
biochemical and metabolic processes
using Tc-99m, Ti-201, or Co-57. |
| Mode of Action | Image acquisition of radioactive
nucleotide distribution by scintillation
cameras | Image acquisition of radioactive
nucleotide distribution by scintillation
cameras |
| Design | Open gantry supporting a fixed 90
degree dual head detector and a
patient table | Open gantry supporting a fixed 90
degree dual head detector and a patient
table |
| Method of Operation | Operated through interaction with an
acquisition and processing computer
system | Operated through interaction with an
acquisition and processing computer
system |
| Intrinsic spatial
resolution - Center
FOV | FWHM: ≤3.5mm
FWTM: ≤7.4mm | FWHM: ≤2.8mm
FWTM: ≤2.9mm |
| Intrinsic spatial
resolution - Useful
FOV | FWHM: ≤3.7mm
FWTM: ≤7.6mm | FWHM: ≤5.4mm
FWTM: ≤5.6mm |
| Intrinsic Spatial
Linearity - Center
FOV | Differential: ≤0.4mm
Integral: ≤0.8mm | Differential: 0.18mm
Integral 0.38mm |
| Intrinsic Spatial
Linearity - Useful
FOV | Differential: ≤0.5mm
Integral: ≤1.0mm | Differential: 0.20mm
Integral: 0.40mm |
| Intrinsic Uniformity -
Center FOV | Integral: +/- 2.5%
Differential: +/- 1.5% | Integral: +/- 2.4%
Differential: +/- 1.9% |
| Intrinsic Uniformity -
Useful FOV | Integral: +/- 3.0%
Differential: +/- 2.0% | Integral: +/- 2.9%
Differential: +/- 2.4% |
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3
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle with three lines representing its wings and body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MEDX, Inc. % Mr. William Greenrose President & CEO Oserve America, Inc. 220 River Road CLAREMONT NH 03743
NOV 1 4 2008
Re: K082581
Trade/Device Name: C-Quest Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulatory Class: II Product Code: KPS Dated: September 2, 2008 Received: September 5, 2008
Dear Mr. Greenrose:
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 (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.
4
Page 2
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.
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 this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
hope Mr. thang
Joyce M. Whang, Ph.D. Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
:
4.1 Indications for Use Statement
510(k) Number (if known):
K08258/
Device Name: C-Quest
Indications for Use:
The C-Quest system is a dual head system designed to acquire data for cardiac multislice images. The system is intended for use as a diagnostic imaging device. When used with the appropriate radio pharmaceuticals, images are produced representing the internal distribution of radioactivity in the body. The system allows you to acquire data from high resolution three dimensional, static, gated or dynamic images of biochemical and metabolic processes using approved radionuclides within the energy range of 60 – 170 keV such as Tc-99m or TI-201.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH; Office of Device Evaluation (ODE)
Prescription
Use
(Per 21 CFR 801.109)
OR
Over-The-Counter
Use
(Optional Format 1-2-96)
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices,
510(k) Number K082581
Section 4.0
CONFIDENTIAL